215 Biostatistics Jobs

Senior Bioinformatics QA Engineer About Velsera Medicine moves too slow. At Velsera, we are changing that .Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights .Velsera provides software and professional services for :AI-powered multimodal data harmonization and analytics for drug discovery and developmen tIVD development, validation, and regulatory approva lClinical NGS interpretation, reporting, and adoption With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries ! What will you do? Quality Assurance / Test Strategy & Execution Work closely with QA Team and implement QA Practices and strategies according to best practices and quality standards Understand and follow SDLC processes to meet quality goals at the product level Work as part of cross-functional scrum teams ("PODs"), developing applications using agile methodologies Provide guidance and mentor team members on test activities and bioinformatics testing approaches Collaborate with development teams to address bugs and production defects quickly Bioinformatics Testing Expertise Interpret requirements to develop verification & validation test plans for bioinformatics applications Design test cases for sequence analysis software including alignment, variant calling, and annotation Design, create, and maintain bioinformatics data simulators and automated testing frameworks Work with product management to understand functional specifications for genomic applications Execute complex test scenarios and investigate issues in bioinformatics pipelines Documentation & Process Improvement Create comprehensive documentation to record testing phases and provide test execution reports Modify/update test protocols based on requirement changes; perform impact analysis Stay current with new testing tools and strategies in both QA and bioinformatics domains Evaluate and improve testing methodologies for continuous improvement Work with cross-functional teams to ensure quality throughout the product development lifecycle What do you bring to the table? Master's degree in Bioinformatics, Computational Biology or related field 7 + years of experience as software QA, with at least 3 years in bioinformatics or genomics Minimum 2 years working experience as a Bioinformatician or in genomic data analysis Demonstrated experience with Next Generation Sequencing tools (BWA, GATK, SAMtools, Tophat) Strong understanding of genomic data analysis, biostatistics, and data structures Experience with CI/CD pipelines and version control systems (Git) Knowledge of software engineering practices, SQA processes, and methodologies Professional Competencies Exceptional attention to detail and problem analysis abilities Strong communication skills (written and verbal) Ability to absorb complex information and integrate it into testing methodologies Focus on quality and continuous improvement Strategic vision to anticipate testing needs for emerging technologies Persuasiveness in advocating for quality standards and practices Experience in the medical device or life sciences industry Knowledge of handling/processing large genomic datasets Experience with cloud computing platforms (AWS, Azure, GCP) Experience with Docker and containerized applications Understanding of regulatory requirements for clinical software (HIPAA, FDA) Strong expertise in QA automation tools and frameworks (Selenium, RestAssured, Jenkins) Proficiency in Java and at least one scientific scripting language (Python/Java) Benefits Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance. Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support. Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow. Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns. Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable. & Many More...

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies. Key Responsibilities The job tasks listed below outline the scope of the position. Based on current business needs, the application of these tasks may vary. Statistical Trial Design and Analysis Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created. Collaborate with data management in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Participate in peer-review work products from other statistical colleagues. Communication of Results and Inferences Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and to interact with regulators. Therapeutic Area Knowledge Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor. Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training. Minimum Qualification Requirements M.S. or Ph.D. in Statistics or Biostatistics or equivalent with more than 3 Years of relevant experience Other Information/Additional Preferences Statistics, Biostatistics, or equivalent of field study Proficient in the SAS programming language Interpersonal communication skills for effective customer consultation Teamwork and leadership skills Technical growth and application with working knowledge of experimental design and statistics Self-management skills with a focus on results for timely and accurate completion of competing deliverables Resource management skills Creativity and innovation Demonstrated problem-solving ability and strategic thinking Business process expertise associated with critical activities (e.g. regulatory submissions) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Job Description Position Summary The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality. The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams. As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects. Principal Responsibilities As a Programming Lead; Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality. Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures. Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals. As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality. As an experienced Statistical Programmer; Designs and develops programs in support of sophisticated clinical data analysis and reporting activities. Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality. May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects. May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities. Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment. Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures. Proven experience planning and coordinating programming activities and leading teams. Proven experience working with cross functional stakeholder and teams. Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Basic project management skills. Demonstrated written and verbal communication skills. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable) Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Exposure or have working experience on real-world data or real-world evidence Preferred Requirements: Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience or solid knowledge in other software, such as R/R-Shiny If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India Job Description: Principal Clinical Programming Lead Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities: Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Education and Experience Requirements: Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience and Skills Required: Approx. 10 -12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11). Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.

Institute of Statistical Science Postdoctoral Researcher and/or Research Assistant Job Description Unit Institute of Statistical Science JobTitle Postdoctoral Researcher and/or Research Assistant Work Content Assist the cooperative with statistical consulting and related services. Responsible for data analysis tasks, including data preprocessing, database construction, data analysis, and report writing. Participate in various activities organized by the Institute of Statistical Science and the cooperative. Assist with administrative affairs of the cooperative. Complete other tasks assigned as needed. Qualifications Research assistant requires a master's degree, and postdoctoral researcher requires a doctoral degree in Statistics or Data Science related fields. Knowledge in "Biostatistics," "Generalized Linear Models," "Multivariate Analysis," and "Categorical Data Analysis” is required Must be familiar with programming languages such as R, SAS, Python, with experience in database development/maintenance and application being a plus. Priority given to candidates with experience in statistics and scientific computing, as well as various types of data analysis. Preference given to candidates with expertise in biostatistics or bioinformatics. Working Environment Operating Hours 08:30~17:30 Work Place Institute of Statistical Science, Academia Sinica Treatment Based on the institute's salary standards and individual qualifications and experience (starting at NT$62,776 for Ph.D. holders, NT$43,624 for master's degree holders). Reference Site http://disc.stat.sinica.edu.tw/ Acceptance Method Contacts Dr. Shu-Chun Chen Contact Address No.128, Academia Road, Section 2, Nankang, Taipei, Taiwan Contact Telephone 2783-5611 ext. 476 Email scchen@stat.sinica.edu.tw Required Documents Resume in both Chinese and English (including autobiography), transcripts from university and above, and other beneficial documents for review. Precautions for application Application Method: Interested parties, please email the required documents to scchen@stat.sinica.edu.tw. Suitable candidates will be notified for an interview. Documents will not be returned. Date Publication Date 2024-08-08 Expiration Date 2025-12-31

About Kozhnosys: Kozhnosys is a healthcare innovation startup pioneering non-invasive cancer diagnostics through exhaled breath analysis. As we expand our operations nationally, we are seeking a Clinical Trial Manager to lead the execution of our clinical studies with scientific rigor and operational excellence. Role Summary: The Clinical Trial Manager (CTM) will oversee the planning, execution, and reporting of clinical trials for Kozhnosys’ diagnostic technologies. This role requires a strategic thinker with hands-on experience in clinical operations, regulatory compliance, and cross-functional coordination. The CTM will ensure that trials are conducted in accordance with ICH-GCP, local regulations, and internal SOPs, while maintaining the highest standards of data integrity and patient safety. Key Responsibilities: Design and manage prospective and retrospective diagnostic studies. Develop clinical trial protocols, case report forms (CRFs), informed consent documents, and study manuals. Coordinate with principal investigators, CROs, and regulatory bodies to ensure timely approvals and site readiness. Oversee site selection, initiation, monitoring, and close-out activities. Travel to different site locations across India and monitor progress and compliance. Ensure compliance with ethical standards, GCP, and regulatory requirements in India, and other jurisdictions. Lead cross-functional teams including data management, biostatistics, and QA to ensure trial milestones are met. Monitor trial progress, manage risks, and implement corrective actions as needed. Prepare clinical performance evaluation reports, including sensitivity, specificity, and ROC analysis. Present trial updates to internal stakeholders, investors, and regulatory authorities. Prepare manuscripts based on study results in international journal. Apply for government grants and other funding opportunities for conducting clinical trials. Represent company in medical conferences and present the trial data. Manage team of clinical trial coordinators at different study centers. Qualifications: Master’s degree or higher in Life Sciences, Pharmacy, or related field. Minimum 5 years of experience in clinical trial management, preferably in diagnostics or medical devices. Strong knowledge of ICH-GCP, ISO 14155, and regulatory frameworks in India, Europe and North America. Experience with observational study designs and diagnostic accuracy studies. Excellent communication and stakeholder management skills. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Preferred: Experience with breath-based diagnostics or sensor-based medical technologies. Certification from ACRP or SOCRA. Prior involvement in early-stage startup environments.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Key Responsibilities Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience Minimum Requirements Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Exposure or have working experience on real-world data or real-world evidence Preferred Requirements Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience or solid knowledge in other software, such as R/R-Shiny If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

We are looking for an experienced Data Scientist to work at one of our global biopharma customers on a range of Biostats models consulting and development engagements. They are expected to bring extensive knowledge in best practices on R package development, model development and deployment on Databricks, collaboration with version control systems, and familiarity with other topics such as data architecture and cloud infrastructure. Desired Skills and experience Candidates should have a B.E./B.Tech/MCA/MBA in Finance, Information Systems, Computer Science or a related field Strong experience in R programming and package development Proficiency with GitHub and unit testing frameworks. Strong documentation and communication skills. A background or work experience in biostatistics or a similar discipline (Preferred). Expert knowledge in Survival Analysis (Preferred) Statistical model deployment, and end-to-end MLOps is nice to have. Having worked extensively on cloud infrastructure, preferably Databricks and Azure. Shiny development is nice to have. Can work with customer stakeholders to understand business processes and workflows and can design solutions to optimize processes via streamlining and automation. DevOps experience and familiarity with software release process. Familiar with agile delivery methods. Excellent communication skills, both written and verbal Extremely strong organizational and analytical skills with strong attention to detail Strong track record of excellent results delivered to internal and external clients Able to work independently without the needs for close supervision and also collaboratively as part of cross-team efforts Experience with delivering projects within an agile environment Key responsibilities include: Evaluate and document R packages, including metadata and user-focused use cases. Develop unit tests aligned with best practices in R package development. Collaborate closely with internal stakeholders. Design and implement technical solutions for Survival Analysis, based on statistical and business requirements Develop professional quality R packages. Provide consultancy on Biostats model development and deployment best practices. Review and optimize code, integrate existing modelling code into packages. Design and implement end to end modelling and deployment process on Databricks. Support and collaborate with adjacent teams (e.g. products, IT) to integrate the modelling solution. Continually innovate with the team and the customer on using modern tooling to improve model development and deployment. Demonstrate high attention to detail, should work in a dynamic environment whilst maintaining high quality standards, a natural aptitude to develop good internal working relationships and a flexible work ethic Responsible for Quality Checks and adhering to the agreed Service Level Agreement (SLA) / Turn Around Time (TAT)

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Clinical Data Sciences (CDS) Key to client success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Clinical Data Configuration Specialist (CDCS), Clinical Data Sciences (CDS): Key to client success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer. Work with Data Engineer to configure (Extract Transform Load)ETLs and (Extract Load and Transform)ELTs. Provide testing and documentation for data pipelines. Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks. Under the guidance of Clinical Data Engineer, the Clinical Data Configuration Specialist configures and maintains the data pipelines that conform to the common data model that ensures data ingestion for all study-level data capture technologies and other related vendor and/or applications (e.g., EDC, IRT, ePRO, eCOA). Coordinates cross functionally, facilitates test data transfer, and confirms accurate DTA specification. Performs tasks to, configure, maintain, and monitor data flow integration between collected data and the clinical data repository (CDR). CDCS contributes to the successful conduct of client clinical trials and to the delivery of high quality in a timely manner, which is eventually used for statistical analysis and submitted to regulatory authorities for the approval of client products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout client research groups to maximize value and achieve company objectives. Key Accountabilities: Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer Partner closely with internal/external stakeholders and data engineers in a collaborative manner Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business Additional Activities: Assists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines Qualifications: Bachelor's degree plus 5 years /Masters with 3 years in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job. Experience with EDC build, Data Management, and EDC extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of XMLS, ALS, APIs and MDR preferred. Experience with one of these languages: SQL, SAS, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification expected Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (Microsoft Office). Experience with EDC build or data extraction configuration ETL/ELT experience Understanding of AWS/Data bricks concepts Preferable but not required: Experience developing R shiny and Python apps Experience with Hadoop Experience with Agile development methods Experience with Veeva CDB Supervision: Supervision required, should be able to function collaboratively (with guidance) with all levels of employees. License/Certifications: Preferred to have SAS or R or Python certification, Physical Demands: Ability to sit and stand for long periods of time. Carrying, handling, and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. Show more Show less

Role & responsibilities Programming: Proficiency in both SAS and R languages, including syntax, data manipulation techniques, and statistical modeling. Data Analysis: Experience with data extraction from various sources, cleaning, preprocessing, and statistical analysis using SAS and R. Statistical Modeling: Ability to apply various statistical models, including linear regression and mixed-effects models, in both SAS and R. Reporting and Visualization: Experience with creating reports (e.g., using Qlik or R Markdown) and visualizations to communicate findings effectively Troubleshooting: Strong analytical and problem-solving skills to troubleshoot and resolve complex issues in SAS and R code. Communication: Ability to communicate technical concepts to non-technical stakeholders effectively. Collaboration: Experience working in a team environment and collaborating with other professionals, such as biostatisticians Under moderate guidance, designs, develops, evaluates and modifies SAS and R programs to analyze and evaluate clinical data. Plans, writes and executes statistical programs in SAS and R designed to analyze data from database. Produces tables, listings and figures. Assesses data accuracy and consistency. Extract data from the SAS system and developed R scripts to clean, preprocess, and analyze data. Application of advanced statistical models, including linear regression and mixed-effects models

🚨 Vacancy Notification | Monitoring & Evaluation Officer 📍 Location: District Una, Himachal Pradesh 🗓️ Apply by: 25th June 2025 We are hiring a Monitoring & Evaluation Officer for the Pilot Scale-up Programme of WINGS Interventions in District Una, Himachal Pradesh. 📌 About the Organization: The Society for Applied Studies (SAS) is a leading public health research organization, recognized as a WHO Collaborating Centre, ICMR Centre of Excellence, and Scientific & Industrial Research Organization. Since 1990, SAS has worked in maternal and child health, nutrition, vaccine evaluation, disease surveillance, and implementation research. 🔗 https://sas.org.in 📌 About the Project – WINGS: WINGS (Women and Infants Integrated Interventions for Growth Study) has shown significant improvements in birth outcomes and early childhood development. SAS, in collaboration with the Government of Himachal Pradesh, NITI Aayog, ICMR, and BIRAC-GCI, is now implementing a pilot scale-up of the WINGS package covering health, nutrition, psychosocial care, and WaSH for women (preconception & pregnant) and young children. 👤 Position: Monitoring & Evaluation Officer 📍 Location: Una, Himachal Pradesh 🕒 Duration: Fixed term (extendable based on performance and project needs) 💰 Salary: Commensurate with experience 🎯 Key Responsibilities: Develop and manage ODK-based data systems Ensure accurate and timely data management from field operations Perform regular data quality checks and audits Conduct data extraction, cleaning, and analysis Create dashboards and contribute to progress reports and presentations Share insights with the program team to inform decisions 📘 Qualifications & Skills: Postgraduate in Biostatistics, Public Health, Epidemiology, Data Science, or a related field At least 2 years of experience in data handling, preferably in public health projects Proficiency in ODK tools, MS Excel, Stata or R Experience with data visualization tools (PowerBI, Tableau, or Looker) Excellent analytical and communication skills Ability to work in cross-functional teams and in rural field settings 📧 How to Apply: Email your updated CV to sarmila.mazumder@sas.org.in and jaideep.kumar@sas.org.in 📝 Subject line: “Application – Monitoring & Evaluation Officer – WINGS Scale-up” 🗓️ Deadline: 25th June 2025 🔁 Please help spread the word by sharing this with professionals passionate about public health, data, and rural health systems. #Hiring #MonitoringAndEvaluation #PublicHealthJobs #DataScienceJobs #ODK #Stata #PowerBI #HealthData #WINGSProject #Biostatistics #RStats #NutritionIntervention #WaSH #DevelopmentJobs #SocialImpactJobs #IndianNGOs #ResearchCareers #JoinOurTeam #ImplementationScience #EvidenceBasedPolicy #HealthSystems #DashboardDesign #FieldBasedJobs #MCH #DataForDevelopment #SocietyForAppliedStudies #HimachalPradeshJobs Let me know if you'd like a version adapted for your organization's official website or as a visual poster for sharing. Show more Show less

Job Description Position: Medical Coder Ct: HR HR Shanmugapriya - 8072891550 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility All (UG/PG) Life Science Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident Emergency Care Technology Audiology speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre Anesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Ct: HR HR Shanmugapriya - 8072891550 This job is provided by Shine.com Show more Show less

Ct HR Lavanya - 9566157632 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility: All (UG/PG) Life Science& Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre & Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology & Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident & Emergency Care Technology Audiology & speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre & Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident & Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre & Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology & Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement: Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Tirumala,Tirupati,Hyderabad,Vizag,Eluru,Kakinada,Ongole,Anantpur,Bhimavaram,Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Reach Us: Ct: HR Lavanya - 9566157632

Job Title: Senior Data Engineer – Financial & Clinical Data Domain (Databricks/AWS) Job Summary: We are seeking a highly skilled and experienced Data Engineer with deep expertise in Databricks and a proven track record working with financial data , dashboard development , and Microsoft Dynamics . This position will support both clinical research and financial analytics , focusing on building scalable, governed data solutions within the AWS ecosystem . The ideal candidate has strong ETL development skills, cloud infrastructure experience, and a business-oriented mindset that translates complex data into actionable insights. Key Responsibilities: Design and develop scalable data pipelines using Databricks and Apache Spark to support clinical and financial data operations. Integrate and orchestrate complex workflows using AWS Glue , AWS Lambda , and Step Functions . Build and maintain enterprise-grade data solutions leveraging Amazon RDS (SQL Server/Oracle) , Amazon S3 , DynamoDB , and integrations with Microsoft Dynamics 365 . Design and deliver dynamic, user-friendly dashboards and data visualizations to support executive-level financial and operational reporting. Lead and mentor a team of data engineers, setting best practices in design, performance, and code quality. Deploy, manage, and optimize cloud infrastructure in AWS , focusing on performance, scalability, and security. Implement strong data governance and master data management (MDM) frameworks to ensure consistency and compliance across systems. Collaborate with stakeholders from finance , clinical operations , IT , and biostatistics to ensure alignment of data products with business needs. Ingest and analyze data from ERP systems like Microsoft Dynamics , driving automation and cross-functional insights. Required Qualifications: 5+ years of experience in ETL Data Engineering across clinical and/or financial domains. 3+ years of hands-on experience with Databricks and Apache Spark . 2+ years of experience integrating data from Microsoft Dynamics 365 or similar ERP/CRM platforms. 3+ years of experience building dashboards in Power BI , QuickSight , or similar tools for financial and operational reporting. 2+ years of experience with AWS Glue , AWS Lambda , and Step Functions or similar orchestration tools. 4+ years of experience with Amazon RDS (SQL Server/Oracle) , S3 , and data lake architecture on AWS. 2+ years of experience deploying and managing infrastructure on AWS cloud . 4+ years of experience leading engineering teams or technical squads. 2+ years of experience implementing data governance and MDM frameworks . Familiarity with GitHub Actions , Jenkins , or other CI/CD tools . Nice to Have: Strong proficiency in Python for scripting and data processing. Understanding of Agile and DevOps methodologies in data environments. Experience with financial forecasting , budget analytics , or regulatory reporting in financial or healthcare sectors. Knowledge of clinical data standards and compliance protocols in CRO/pharma industries. Show more Show less

Overview Please Note: You may be required to travel to our Mumbai office based on business requirements or for company/team events. If you are looking for challenging and rewarding work which combines your understanding of medical science and aptitude for writing into one unique job, the Medical Writer role is for you. This is an opportunity to grow your career and make a greater impact on the lives around you. Responsibilities Use scientific expertise to develop (write, proofread, and data-check) high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, posters, manuscripts, MSL/training slide decks, infographics, congress and meetings materials, literature searches and reviews, standard response letters/medical information letters, and HCP engagement content according to client needs with excellent attention to detail under the guidance of the scientific leads Liaise and build trusting and professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders including authors, reviewers and key opinion leaders across therapeutic areas -- learning to anticipate their needs Effectively and proactively communicate with team members, authors/faculty, clients and vendors Attend workshops/seminars/trainings to hone your skills and contribute to organizational objectives Attend client and other external meetings and supporting senior team members as needed Apply your scientific and creative knowledge and work closely with client directors in developing ideas and executing effective medical communications initiatives in the digital space, including publication extenders, creation of infographics, interactive assets, website content, patient narratives, and medical information engagement plans You will be responsible for ensuring all materials follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable), and CACTUS’ internal SOPs. Any updates to either of these items should be made consistently and documents should remain up to date. Perform as a document specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences as appropriate, by maintaining current awareness of developments across therapeutic areas or disciplines Share best practices and client preferences, thereby contributing to skill development within the medical communications team Qualifications And Prerequisites 1-3 years of experience in relevant fields of scientific writing PhD/MD (Pharmacology) OR PhD (Life Sciences) OR PharmD with a good understanding of clinical research and medical communication Should have experience working on publications Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills Excellent communication skills, especially with the clients Ability to adapt writing style to different materials and target audiences Basic knowledge of biostatistics Literature reviewing and evaluation capabilities Very good working knowledge of MS Office Application Process Before applying, please ensure you meet the role requirements listed above and have legal authorization to work in the country where this role is advertised. Our selection process typically involves an initial screening by a recruiter, a technical assessment, and two to three interview rounds. Equal Opportunity Our hiring practices reflect our commitment to providing equal opportunities and creating an environment where everyone can thrive, develop, and succeed. We celebrate the uniqueness of our team members and prohibit discrimination of any kind, based on race, color, religion, gender identity, sexual orientation, age, marital status, disability, or any other protected characteristic. Accelerating from Anywhere As a remote-first organization, these are essential attributes we look for in all our candidates. Taking ownership of your work with minimal supervision, showing strong ability to organize, prioritize and deliver results independently. Documenting work that brings everyone on the same page. Maturity to choose between synchronous and asynchronous collaboration. Effectively collaborating with colleagues across different time zones by setting dedicated hours for collaboration and keeping team members updated through your MS Teams status. About CACTUS At Cactus Life Sciences (cactuslifesciences.com), we believe the future of medical communications lies at the intersection of science, technology, and human connection. Headquartered in Princeton, New Jersey, with teams in Switzerland, the United Kingdom, India, and Japan, we help biopharmaceutical organizations redefine scientific exchange—leveraging AI, automation, and innovation while keeping patients at the heart of everything we do. Our expertise spans medical strategy, scientific content development, and medical education across therapeutic areas and the product lifecycle. By blending scientific rigor, agile operational models, and future-ready technologies, we partner with medical affairs teams to catalyze their transformation, adapt to a changing landscape, and drive meaningful outcomes for healthcare communities worldwide. Show more Show less

What will you do? Quality Assurance / Test Strategy & Execution Work closely with QA Team and implement QA Practices and strategies according to best practices and quality standards Understand and follow SDLC processes to meet quality goals at the product level Work as part of cross-functional scrum teams ("PODs"), developing applications using agile methodologies Provide guidance and mentor team members on test activities and bioinformatics testing approaches Collaborate with development teams to address bugs and production defects quickly Bioinformatics Testing Expertise Interpret requirements to develop verification & validation test plans for bioinformatics applications Design test cases for sequence analysis software including alignment, variant calling, and annotation Design, create, and maintain bioinformatics data simulators and automated testing frameworks Work with product management to understand functional specifications for genomic applications Execute complex test scenarios and investigate issues in bioinformatics pipelines Documentation & Process Improvement Create comprehensive documentation to record testing phases and provide test execution reports Modify/update test protocols based on requirement changes; perform impact analysis Stay current with new testing tools and strategies in both QA and bioinformatics domains Evaluate and improve testing methodologies for continuous improvement Work with cross-functional teams to ensure quality throughout the product development lifecycle Requirements What do you bring to the table? Master's degree in Bioinformatics, Computational Biology or related field 7 + years of experience as software QA, with at least 3 years in bioinformatics or genomics Minimum 2 years working experience as a Bioinformatician or in genomic data analysis Demonstrated experience with Next Generation Sequencing tools (BWA, GATK, SAMtools, Tophat) Strong understanding of genomic data analysis, biostatistics, and data structures Experience with CI/CD pipelines and version control systems (Git) Knowledge of software engineering practices, SQA processes, and methodologies Professional Competencies Exceptional attention to detail and problem analysis abilities Strong communication skills (written and verbal) Ability to absorb complex information and integrate it into testing methodologies Focus on quality and continuous improvement Strategic vision to anticipate testing needs for emerging technologies Persuasiveness in advocating for quality standards and practices Experience in the medical device or life sciences industry Knowledge of handling/processing large genomic datasets Experience with cloud computing platforms (AWS, Azure, GCP) Experience with Docker and containerized applications Understanding of regulatory requirements for clinical software (HIPAA, FDA) Strong expertise in QA automation tools and frameworks (Selenium, RestAssured, Jenkins) Proficiency in Java and at least one scientific scripting language (Python/Java) Show more Show less

Summary To support the development, dissemination, and maintenance of Value & Access deliverables for selected key strategic asset/s for a specific disease/condition. Deliverables: Indirect treatment comparison, Cost effectiveness models, budget impact models and their updates, and other activities as directed by clients across Novartis About The Role Location – Hyderabad About The Role: To support the development, dissemination, and maintenance of Value & Access deliverables for selected key strategic asset/s for a specific disease/condition. Deliverables: Indirect treatment comparison, Cost effectiveness models, budget impact models and their updates, and other activities as directed by clients across Novartis Key Responsibilities: Develop optimal knowledge and experience in Health Economic Modeling and Evidence Synthesis Develop and maintain the qualitative and/or quantitative deliverables as per the client requirements in accordance with the agreed standard process and timelines Liaise with clients on project schedule/planning of deliverables Ensure that the new associates/junior colleagues deliver quality deliverables by providing guidance and performing QC/review Support clients to conduct feasibility assessment and update indirect treatment comparisons as and when required Deliver adhoc trial data based statistical requests and activities Support the development of additional guidance and training materials (i.e. checklists, QA processes etc.) Develop long-term, peer-level relationships with key clients Take responsibility and accountability to train, mentor, coach and also ensure functional development of new associates/junior colleagues within V&A team Perform effective project management and stake-holder management Contribute to V&A initiatives / work-streams Complies with and support group’s project management tool, standards and policies. Maintains records for all assigned projects including archiving. Maintains audit, SOP and training compliance Essential Requirements: Undergraduate degree in a relevant scientific discipline plus graduate degree (Masters or PhD) in relevant discipline (including health economics, statistics, biostatistics, epidemiology, health services research, public health, or business management) Proficiency in ‘English’ is a pre-requisite; while knowledge of other in-scope country languages would be an advantage Pharmaceutical domain knowledge MS-Office skills (MS-Excel, MS-Word, and MS-Power-point) 7+ years conducting Quantitative evidence synthesis or health economic modeling for pharmaceutical products in pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (e.g. clinical research, statistics, epidemiology, trial data analytics) Ability to work, prioritize, and drive projects independently. Commitment To Diversity And Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility And Accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

The Director, Clinical Data Management is responsible to lead, manage and support the departmental or functional team and processes to ensure that Parexel delivers quality projects to its clients and achieves agreed revenue margins. Guide ongoing training, career development and Management processes within the department or function. The Director is responsible to ensure client projects are resourced with suitably developed professionals and to ensure appropriate retention plans are in place to develop and retain these professionals within Parexel. The Director is responsible to promote new business by participating in project bids and client presentations as appropriate. The Director is responsible to provide expertise and consultation to project teams. The Director is an experienced leader responsible for liaising with senior levels or management within the organization to continuously assess and improve operational project delivery. The Director is responsible to lead, manage and successfully deliver key cross-functional initiatives within Global Data Operations. The Director is expected to act as an Account Lead for a key client, group of clients, and/or a specific area of business to provide leadership, excellence in management, and expertise to support all aspects of Data Management projects within an account. The Account Lead provides general oversight, consistency in approach and leadership across an account where an account is covering multiple studies/projects. The Account Lead ensures that the team delivers quality outputs to the client. The Account Lead functions as the key point of contact for the client and senior management of Data Management at Parexel. The Account Lead is responsible to ensure that DM teams involved with studies/projects are adequately trained in the client processes and systems and possess required competencies to carry out assigned tasks including the ability to work in a team environment. The Account Lead will ensure adequate resources are available to support studies/projects contracted within a client account. The Account Lead manages or leads communication, governance, key performance indicator metrics, staff utilization, and resource recruitment strategy/allocation across different regions, ramp-up plan, and performs training modules if needed for the account within remit. The Account Lead is responsible for understanding business objectives and ensures that Parexel achieves agreed revenue margins. The Account Lead is responsible for promoting new business by participating in account specific project bids and client representations as appropriate. The Account Lead is responsible for building relationships across Account Leads in other functions such as Global Data Operations, Strategic Account Leaders (SAL’s), Client Relationship Directors, Business Development (or Enterprise Account), and Quality Management. The Account Lead is responsible for building a mutually beneficial relationship with the client fostering trust and honest on both sides. The Account Lead is responsible for managing issues (or escalating issues if needed) and mitigating risks for both Parexel and Clients, by providing input into or developing contingency plans for the account. Key Accountabilities Departmental Leadership: Provide expertise and consultation, facilitate metrics collection, and develop action plans in conjunction with Data Management and Clinical Database Programming Senior Leadership to improve operational performance. Proactively lead, manage, and successfully deliver key cross-functional initiatives within Global Data Operations. Act as a back-up to Senior Director, Data Management for internal meetings and initiatives. Team Leadership : Ensure team delivery of high-quality project deliverables by monitoring performance Train and mentor team according to job role expectations Meet with full team on a regular basis with comprehensive communication and guidance Independently execute the full range of duties relevant to the leadership, management, and development of team members to ensure their performance meets or exceeds Manage and oversee departmental activities including appropriate resourcing of staff, staff assignments, quality control and timely delivery of project deliverables Recruiting, developing, and retaining a skilled, experienced, and motivated team Maintain an agreed level of productivity, billability, and staff turnover Awareness around team performance and impacts to accounts team is contributing to, collaborate with Account Lead colleagues where AL is not LM. Promptly deliver positive and constructive feedback to team members and lead formal staff review processes e.g. performance and salary reviews to corporate standards and timescales May be escalation point of contact for clients managed by direct reports Account Leadership : Point of contact for clients and within Parexel for account specific matters requiring escalation to senior management Proactively identify potential issues/concerns related to DM on the account that may adversely affect strategic partnership with the client and communicate those to senior management for preemptive measures Maintain and strengthen effective working relationship with Biostatistics Account Lead on mutual accounts Maintain seamless communication with the account staff to ensure study/project progress, timelines, quality, budget and all the deliverables are being met with quality Implement strategies for the maintenance and growth of the partnership to ensure that deliverables are of high-quality including representation and successful support for bid pursuit meetings Own and maintain partnership training curricula Oversee and coordinate the implementation of client processes (if applicable) and optimization of those processes (LMS Review, Training modules creation, maintain SOP list, process update communication, authoring/customizing partnership process documents, mentoring, etc.) Assigned as QI manager on partnership QIs Work with each regional head and plan for long term recruitment strategy Oversee/review resource requirements across the portfolio of studies/projects within a client and communicate with Sr. Management at Parexel Collaborate with Project Management Office and Project Quality Lead to oversee/calculate KPI/Metrics for account Oversee/review financial score of an account and generate summary table Facilitate “Lessons Learned” after project completion and determines improvement opportunities within the Account Have regular meetings with direct reports and staff within an account Attend regular account oversight client meetings (such as weekly meetings, monthly functional management team meetings, quarterly operational management team meetings, bi-yearly executive steering committee meetings, etc.) Quality Management & Compliance : Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of activities Develop team to independent data collection for KPIs, Metrics, dashboards as applicable Lead reviews of role specific training curricula – as applicable Lead Parexel process documents authoring or reviewing to improve efficiencies and profitability Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements and Parexel processes Check quality of team deliverables and appropriate remedial action. Financial & Resource Management : Ensure appropriate resourcing of team Proactively plan and support financial excellence Drive team compliance and proper execution of financial reviews Provide feedback on team financials and resourcing through collaboration with Subject Matter Experts . Initiatives & Business Development : Lead and Contribute to bid pursuit activities by supporting team and/or attending bid pursuit opportunities, including new partnership opportunities Lead and/or Participate in Parexel and department system/standards improvement activities Train/Mentor new managers where appropriate. General Activities : Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims). Skills: The Director, Data Management position at Parexel requires a diverse skill set across three main categories: Leadership, Personnel Management, and Business Operations. Leadership Skills : Excellent ability to build and lead virtual teams independently and with authority Strong ability to manage managers and/or individual contributors Outstanding negotiation and organizational skills Excellent analytical and problem-solving skills Excellent communication skills with a diplomatic approach including the ability to work with various personalities and perspectives Excellent ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail Effective time management to meet objectives Excellent ability to lead cross-functional initiatives within Global Data Operations Demonstrated proactive thought process to minimize and mitigate risk independently Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development Ability to make appropriate decisions in ambiguous situations. Personnel Skills: Excellent interpersonal, oral, and written communication skills Strong ability to gain trust and confidence with a variety of clients as well as within Parexel Excellent learning ability and flexibility Excellent managerial courage, resilience, and ability to adjust to a rapidly changing environment. Excellent presentation skills: internal, external, and to large audiences (including experience or willingness to participate in conference presentations) Work with integrity Competent in written and oral English and local language (as applicable) Ability to travel as required Business Operations Skills : Comprehensive knowledge of relevant software Excellent commitment to Quality Full understanding of GDO tasks, specifically within Data Management and Database Programming, regulatory requirements, and data standards Ability to identify any bottlenecks during operational processes and bring to the attention of the senior management team at Parexel while, in tandem, providing the client with potential solutions Lead and guide clients to finalize Key Performance Indicators (KPIs)/metrics Maintain maximum utilization of self and team Drive team compliance to SOPs Knowledge and Experience: Significant work experience in similar position Acted in a leadership role in their area of expertise Strong, proven record of leading project and program teams, including previous line management experience with proven team success Excellent understanding of cross functional activities Demonstrated and comprehensive patient and customer service focus Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures Education : Bachelor’s degree preferably in a science or industry- related discipline or equivalent experience Master’s degree preferably in a science or industry-related discipline or equivalent experience Certification or involvement in a professional society or organization is recommended Show more Show less

📢 We’re Hiring: Senior Faculty in Epidemiology 📍 School of Science | Woxsen University | Hyderabad Are you passionate about shaping the future of public health and epidemiological research? Woxsen University, a hub of academic excellence and innovation, is inviting applications for the position of Senior Faculty in Epidemiology within the School of Science. 🔬 Position: Senior Faculty – Epidemiology 📌 Location: Woxsen University, Hyderabad 📅 Application Deadline: 27/06/2025 (Before 5:00 PM) Key Responsibilities: Lead teaching and curriculum development in Epidemiology and Public Health. Supervise graduate and postgraduate research scholars. Conduct high-impact interdisciplinary research and publish in reputed journals. Collaborate with healthcare, government, and international agencies on research and outreach initiatives. Eligibility Criteria: Ph.D. in Epidemiology / Public Health / Biostatistics or a closely related field. Minimum 8–10 years of teaching and research experience. Strong publication record in high-impact journals. Proven ability to secure research funding and lead academic teams. What We Offer: Competitive compensation and benefits. State-of-the-art campus and research facilities. Opportunities for global collaboration and research funding. A vibrant, inclusive academic community. 📨 Apply Now: Send your detailed CV and cover letter to biotech.sos@woxsen.edu.in Join Woxsen University and be a part of a transformative journey in health sciences education and research. Empower. Innovate. Lead. Show more Show less