268 Clinical Data Jobs - Page 4

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The clinical automation team focuses on the development and implementation of innovative concepts and application for our client across different accounts in operations. The team is responsible for designing and implementing highly interactive scalable web apps and prototypes at enterprise level.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, Python, Full- Stack Developer. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamBachelors degree in Computer Science, Information Technology, Engineering or any computer related discipline.Work experience of at least 3 year in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.).Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions.Work experience in Implementing APIs based architecture frameworks.Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment.Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations.Design and implement highly interactive, scalable web apps and prototypes at Enterprise level.Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly.Implement APIs based on architecture frameworks and guidelines.Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines.Able to lead Automation initiatives within his account.Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution.Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain.Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You should be able to pilot and deploy automation solutions at scale.Partner with the testing team to ensure applications/components are fully functional.Oversee and fix any defects or performance problems discovered in testing.Participating in analyses of requirements as well as functional design whenever necessary.Be involved in the design of the solution.Performing design, coding, application maintenance and testing activities.Take ownership of the successful implementation of the solution. Qualification BE,BTech,MCA

Job Description We are currently seeking a Study Nurse to join our growing team. The role will include the following: Checking vital signs as per SOP and protocol and filling in the vital CRF Reporting and assisting in the management of any adverse event(s) Maintaining and updating stock of emergency medicines and filling up of the relevant forms IV cannulations and collection of blood samples during study and screening Filling the respective logbook meant for emergency medicines Labeling of vacutainers, Checking the labels of vacutainers and cryo vials Management of BA/BE and ICU wards Maintenance of ICU ward instruments and the respective logbooks Ensuring the relevant study procedures are carried out in compliance with SOP and protocol Ensuring disposal of bio waste as mentioned in the SOP Recording the temperature and humidity of the Ward, sample collection and ICU Ensuring availability of adequate stock materials required for phlebotomy and medical related activities in upcoming studies Volunteer registration and checking BMI during screening of volunteers Investigation product administration Updating contract staff training files. Screening and registration activities. Compilation of screening reports and study reports, entering lab values. Segregation of the samples. Desirable Skills and Experience 0 2 years experience with Nursing Council registration Good communicator Computer literate Manipal, India ANM/GNM/BSc Nursing Entry Level Clinical Research

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 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: 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 Bachelors 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.

the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team." Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Lead Clinical Data Science Programmer- Office based- Bengaluru/ Chennai/ Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Lead Clinical Data Science Programmer to join our diverse and dynamic team. As a Lead Clinical Data Science Programmer at ICON, you will play a key role in designing and developing clinical data solutions, ensuring the efficient handling, analysis, and reporting of complex clinical trial data. You will collaborate with cross-functional teams to drive data-driven insights that support the advancement of cutting-edge therapies and innovative clinical research. What You Will Be Doing: Leading the design, development, and validation of data science programming solutions for clinical trials. Collaborating with biostatisticians, data managers, and clinical teams to develop data specifications and analysis plans. Programming and validating datasets, tables, listings, and figures (TLFs) according to study requirements. Ensuring the accuracy, consistency, and integrity of clinical data through rigorous quality control and validation checks. Mentoring and guiding junior programmers and providing technical leadership within the data science programming team. Your Profile: Bachelor s or advanced degree in computer science, biostatistics, data science, or a related field. Extensive experience in clinical data programming, with proficiency in SAS, R, or other relevant programming languages. In-depth knowledge of clinical trial data structures, CDISC standards (SDTM, ADaM), and regulatory requirements. Strong analytical and problem-solving skills, with a focus on data accuracy and quality. Excellent communication and leadership skills, with the ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis datasets and provide QC d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable) .The Senior Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. People : Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (i.e., Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Work closely with the Lead Biostatistician and Lead Programmer to develop and implement project QC plans and timelines. 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Masters degree 6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 3 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology. Languages : Excellent English language knowledge - written and spoken

Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs; Provide Project management to the team in the area of clinical data review and viewed as an expert in data management; Drive the delivery of end-to-end study data quality and integrity; Provide medical, clinical, and scientific advisory expertise. Essential Functions Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data) Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. . Define data capture requirements in line with protocol and reporting needs. Represent clinical data scientist at multi-disciplinary team meetings and external meetings. Maintain strong customer relationships With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions Ensure timely follow-up and resolution of compliance issues Serve as Subject Matter Expert (SME) Continuously look for opportunities to improve efficiency of tasks and quality of deliverables Provide therapeutic area/indication training for the project clinical team. Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. Manage staff in accordance with organization s policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. Qualifications Other Medic with 5 year college degree or MBBS Req Bachelors Degree Clinical, biological, mathematical sciences, or related field, or nursing qualification, with 7 years of relevant work experience Req Equivalent combination of education, training and experience in lieu of degree Req Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req Good understanding of clinical/medical data Proven expertise in the proactive identification of issues Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics Proven ability to work within a matrix team environment requiring minimum level of supervision Attention to detail Interpersonal and analytical skills, Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve Excellent communication, interpersonal, customer service, and teamwork skills Excellent organizational and problem-solving skills Excellent project management skills and coaching skills Ability to work with minimal supervision, using available resources Ability to work on multiple projects and manage competing priorities Strong customer focus skills Ability to establish and maintain effective working relationships with coworkers, managers and clients

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyThe Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Masters in actuarial science

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexible.Ability to perform under pressure.Problem-solving skills.Ability to establish strong client relationship.Agility for quick learning.Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for Adaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,Bachelor of Pharmacy,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Analyst Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification MSc,Bachelor of Pharmacy,Master of Pharmacy

Summary -Junior Specialist for project delivery and/or operations in the given business sub-capability. Partner with Business Stakeholders and TT Strategic Business Partners for project delivery and/or operations. About the Role Major Accountabilities Execute solution implementation according to technology and delivery strategy for business systems, platforms, and processes for a particular service scope. Partner with DD&IT Partners for demand analysis, solution proposal / evaluation, and funding estimates. Deliver products according to strategy and with reusability. Ensure on time, within budget, compliant, secure, and quality delivery of portfolio for responsible service scope. Ensure services, solutions, platforms, products are fit for purpose and achieve the desired business value and impact. Run efficient DevOps for platforms, products, or systems ensuring availability and optimal performance for particular service scope. Follow governance structure for projects, operations, etc with right stakeholder representation. Track, report, and deliver against agreed success factors and KPIs for various stakeholders for responsible service area. Follow DD&IT practices to drive agility, speed, efficiency, and effectiveness. Ensure adherence to Security and Compliance policies and procedures. Additional Specifications Key Performance Indicators (KPIs) Delivery on agreed KPIs including business impact. Launch of innovative technology solutions across Novartis at scale. Business impact and value generated from TT solutions. Adoption and development of Agile, Productization and DevOps practices. Operations stability and effective risk management. Feedback on customer experience. Competencies Digital & Technology Savvy Technical / Functional Skills & Knowledge Audit Methodology: Identifying and Testing Controls for Business Risk Business Case Development Conceptual / Blue sky thinking Contracting with Stakeholders Data Management Demand Planning IT Solution Architecture Knowledge of IT Applications & tools Knowledge of IT Infrastructure & systems Knowledge of project management models and techniques Knowledge of relevant tools and systems Leveraging technology for business and customer needs Commitment to Diversity and Inclusion: 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:

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 About the Role: The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. 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. Minimum requirements MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ 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: Accessibility and accommodation 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:

Key Responsibilities: • Deliver engaging, online training sessions on Clinical Data Management to students and professionals. • Create and update course materials, including presentations, handouts, and assignments. • Could you provide practical examples and case studies to enhance learning? • Conduct assessments and provide feedback to students to monitor their progress. • Stay up to date with the latest industry trends and advancements in Clinical Data Management. • Collaborate with the Biotecnika team to continuously improve course content and delivery. Qualifications: • Bachelor's or Master's degree in Clinical Data Management, Life Sciences, or a related field. • Minimum 2+ years of hands-on experience in Clinical Data Management. • Strong knowledge of clinical trial processes, CDM tools, and regulatory guidelines (such as GCP, FDA, and ICH guidelines). • Prior teaching or training experience is highly desirable. • Excellent communication and presentation skills. • Ability to explain complex concepts in a simple and understandable manner. • Proficient in MS Office and various online teaching platforms. What We Offer: • Opportunity to mentor and shape the future of clinical data management professionals. • Competitive compensation. • Access to Biotecnika's resources and network.

MRM Executive will be responsible for analyzing medical information of US patients on various Electronic Health Record (EHR) platforms. Using predefined rules, they will perform various roles including creating & updating patient charts and orders. Required Candidate profile The role includes data entry tasks, extracting patient medical information from Zoho CRM, and uploads to various EHRs. Assist with billing, accounting, report generation, and maintaining trackers.

Frontera Health is revolutionizing pediatric healthcare by developing a cutting-edge, tech-enabled platform that delivers essential therapies to rural families. Our platform leverages AI/ML to create a robust video-based data model for early intervention and developmental disorders. By collaborating closely with parents, caregivers, and clinical partners, we re bridging the gap in access to care, improving health equity, and providing personalized treatment plans. Backed by leading investors like Lightspeed and Lux, Frontera Health is poised for rapid growth. Our ABA direct services are designed to meet the unique needs of children in underserved communities, providing them with the support and resources they require to reach their full potential. We are passionate about ensuring that every child, regardless of their location or socioeconomic status, has access to high-quality healthcare. By leveraging our technology platform and partnering with local providers, we are able to deliver effective ABA therapy to families who may otherwise have limited access to these essential services. Frontera Health is seeking a Clinical QA & Performance Lead to build and lead the quality systems behind our clinical annotation function. This team is responsible for labeling high-fidelity behavioral health data (video, audio, and text) that directly powers our AI models and clinical product insights. This role is equal parts quality architect, measurement analyst, and clinical systems thinker. You ll define what good looks like, build processes to track it, and ensure that the work we produce meets our clinical and scientific bar. You ll work closely with our Ops, ML, and Clinical teams to ensure that ambiguity is resolved quickly, feedback is integrated thoughtfully, and performance continuously improves. This is a hands-on leadership role with room to shape the future of clinical data quality at Frontera. What You ll Do Own definition and implementation of quality metrics (IOA / inter-rater agreement, audit scores, reviewer calibration) Build and maintain gold-standard datasets to serve as training and validation anchors Design QA workflows that balance precision, scale, and reviewer experience Lead reviewer onboarding and training systems, including calibration exercises and ongoing development Track performance across annotators and reviewers; flag drift and recommend coaching or retraining Partner closely with Ops Manager to align QA expectations with throughput goals Serve as a bridge between clinical subject matter experts, ML teams, and annotators to clarify labeling standards Monitor quality trends over time and drive continuous process improvement Facilitate periodic audits and synthesize findings into actionable recommendations What You ll Bring 4+ years experience in clinical QA, annotation QA, clinical operations, or healthcare analytics Familiarity with behavioral health, healthcare research, or human-annotated datasets Strong understanding of IOA/IRR concepts and metrics (e.g., Cohen s or Fleiss kappa) Experience building or managing QA systems in data labeling, research, or clinical settings Analytical mindset with comfort using tools to track trends, measure performance, and drive change Excellent communication and training skills able to support both junior annotators and senior stakeholders Thoughtful, systems-oriented approach to ambiguity, edge cases, and clinical nuance Bonus: Experience with tools like Label Studio or working in an ML-adjacent environment Why Frontera At Frontera, you ll be part of a mission-driven team using structured clinical data to reimagine pediatric therapy. Your work will directly shape the quality and reliability of the data behind our models and by extension, the care we deliver to families. Join us in building the future of developmental healthcare! We have determined a salary range for this position that takes into account several factors including experience, knowledge, education, skills, and abilities. Please note that the salary information is a general guideline and the exact salary will be determined based on the individual s qualifications and experience, with consideration given to the factors listed above. All full time employee benefits include a stake in shared success through stock options, health benefits, 401(k) plan, and responsible PTO. Expected salary range in Denver $110,000 $130,000 USD Frontera Health, Inc. is committed to creating and maintaining a diverse, equitable, and inclusive workplace where everyone feels valued, respected, and has the opportunity to thrive. We believe that our differences make us stronger and that all employees, regardless of their background, experiences, or abilities, contribute to our success. We are committed to: Providing equal employment opportunities to all qualified individuals, without regard to race, color, religion, sex, national origin, disability status, sexual orientation, gender identity or expression, age, genetic information, veteran status, or any other characteristic protected by law. Fostering a culture of inclusion and belonging where everyone feels valued and respected. Providing reasonable accommodations to employees with disabilities. Continuously learning and improving our DE&I practices. We will achieve this commitment by: Recruiting and hiring a diverse workforce that reflects the communities we serve. Creating and maintaining an inclusive work environment that is free from discrimination and harassment. Actively listening to and addressing the needs and concerns of all employees. We believe that diversity, equity, and inclusion are essential to our success as a company and to our mission of serving the pediatric behavioral health community. We are committed to continuous improvement in this area and welcome feedback from all employees.

Clinical Data Science Lead _ Office Based We are currently seeking a Clinical Data Science Lead to join our diverse and dynamic team. As a Clinical Data Science Lead at ICON, you will play a crucial role in driving data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions. You will contribute to the advancement of innovative therapies by overseeing data science projects and leading a team of data professionals. What You Will Be Doing: Leading the design and implementation of data science strategies to enhance clinical trial data analysis. Collaborating with cross-functional teams to identify key data requirements and analytical needs. Overseeing the development of statistical models and analytical tools to optimize data interpretation. Mentoring and guiding team members in best practices for data analysis and visualization. Communicating findings and insights to stakeholders through presentations and reports, influencing project direction. Your Profile: Advanced degree in statistics, data science, life sciences, or a related field. Extensive experience in data analysis and project leadership within a clinical research setting. Strong expertise in statistical software and data visualization techniques. Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights. Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Data Science Lead _ Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Data Science Lead to join our diverse and dynamic team. As a Clinical Data Science Lead at ICON, you will play a crucial role in driving data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions. You will contribute to the advancement of innovative therapies by overseeing data science projects and leading a team of data professionals. What You Will Be Doing: Leading the design and implementation of data science strategies to enhance clinical trial data analysis. Collaborating with cross-functional teams to identify key data requirements and analytical needs. Overseeing the development of statistical models and analytical tools to optimize data interpretation. Mentoring and guiding team members in best practices for data analysis and visualization. Communicating findings and insights to stakeholders through presentations and reports, influencing project direction. Your Profile: Advanced degree in statistics, data science, life sciences, or a related field. Extensive experience in data analysis and project leadership within a clinical research setting. Strong expertise in statistical software and data visualization techniques. Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights. Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

The Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for analysis datasets and provide QC done data packages including tables, figures, and listings for use in publications (ie, abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) and to investigate the natural history of a TA diseases and long-term treatment outcomes of observational data using clinical trials and / or Registries as applicable; The Principal Biostatistician will ensure SOPs are followe'd, communications, timelines and quality metrics are met.; Collaboration of Local biostatistics and programming teams, Global Medical Affairs biostatisticians and / or programmers, and Global Medical Affairs Scientific Communications personnel. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs. 2) Support Sanofi Business Operations Leadership Team in understanding of stakeholders needs & expectations and provide end to end solutions for TAs/indications. 3) Coach/mentor new team members to support efficient and quick onboarding. 4) Support graduate hiring program as needed. Performance / Process: 1) Conduct appropriate post-hoc or ad-hoc statistical analyses of clinical trial data and / or registry (ie, Observational) data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages eg SAS. 3) Produce we'll documented data packages that include tables, listings, and figures. 4) Work closely with the Team Lead Biostatistician and/or Team Lead Programmer to develop and implement project QC plans, timelines and KPIs. 5) Learn, implement, and share through lecture series at least one indication of disease and product (Immunology, Multiple Sclerosis and Neurology, Rare Diseases, Rare Blood Disorders and Oncology) expertise. 6) Review appropriate biomedical and clinical research literature related to assigned project(s). 7) Active participation and Effective contributing in project governance meeting to proactively discuss risks, issues related to timelines and quality of deliverables. 8) Present your selected / assigned topic in lecture series internal and / or across line functions thereby improving the statistical knowledge and presentation skills. 9) Use Advanced analytical methods & tools to provide dashboards to the stakeholders. Customer: Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Masters degree 8 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology (preferred) and 4 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology Languages : Excellent English language knowledge written and spoken

Summary 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. These tasks are to be performed independently or team based with minimal guidance and supervision. About the Role 1. Produce and track reports for various line functions within Global Drug Development, used for ongoing monitoring of clinical data 2. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders 3. Author /co-author the user requirements document, functional specifications and functional testing scripts 4. Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery. 5. To provide quantitative analytical support to the global program teams, including providing support on analyzing reports 6. Support the planning, execution and close-out of Clinical Programs/Trials. 7. Support the management in collation and delivery of analytics reports for critical decision making 8. Create, file and maintain appropriate documentation 9. Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data 10. Provide necessary training to end-user on best / appropriate and consistent use of various data review tools 11. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R. 12. Good Knowledge of Novartis Clinical Data Standards and its implementation for creation of reports specifications or reports output 13. Support special projects of limited scope (sub team lead, local project, etc. ) both clinical and non-clinical in nature. 14. Provide study level expertise and involvement in CTTs. 15. Lead or provide support to special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues, processes, user support, training, etc. 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:

Hiring: Team Lead Clinical Trials | Work from Office | Pune Location: Kothrud, Pune Shift: Evening / Night Job Type: Full-time (Work from Office) Salary: As per experience and best in industry Job Description: We are hiring for the position of Team Lead Clinical Trials . The role involves end-to-end management of clinical trial operations with a strong focus on quality, compliance, and timelines. The ideal candidate will lead cross-functional teams, manage client communication, and ensure the smooth execution of projects. Key Responsibilities: Lead teams including operations managers, team leads, quality analysts, and support staff. Monitor workflow and performance to identify and resolve issues. Provide mentorship and support to team members to promote a high-performance culture. Manage client onboarding, workflow planning, and quality assurance. Ensure compliance with industry regulations and client expectations. Present operational updates to senior management. Act as the primary contact for client communication and relationship management. Required Qualifications: Bachelors degree in Pharmacy or Life Sciences. 5 to 8+ years of experience in clinical research (BPO/KPO environment). At least 2 to 4+ years of experience in a leadership or team management role. Strong verbal and written communication skills. Excellent organizational and multitasking abilities. Work Environment: This is a Work from Office role based in Pune. Benefits: Competitive salary package. Health insurance and paid time off. Professional growth and learning opportunities. Only Walk-In Interviews Interested Candidates Can Contact: Sanjana 9251688426

Clinical Research Physician ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Job Advert Posting At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. JOB FUNCTIONS/RESPONSIBILITIES: Serve as medical team leader on assigned projects, Ensure provision of all contracted activities and identification of out of scope activities on projects assigned Medical review of clinical trial data, including review of Laboratory alerts, Electrocardiogram (ECG) alerts, data from eCRF/ EDC (listing review/ Patient profile review), Eligibility review, Identify protocol deviations, coding review and preparation of Medical Monitoring Reports as per requirement Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by central laboratories CRF safety review Contribute any necessary medical input into integrated clinical and statistical reports Assist in making presentations to potential clients when appropriate Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations Represent ICON Medical Affairs at teleconferences and meetings Liaise with Sponsors regarding medical issues and medical consultation Ensure quality of medical deliverables in accordance with project plans and ICON Standards Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention QUALIFICATIONS/EXPERIENCE REQUIRED: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Medical degree and broad based post graduate clinical experience Solid work experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills Proficiency in English, Good oral and written communication skills Ability and willingness to travel on an as-need basis Excellent presentation skills Good computer skills (MS: Outlook, Word, Excel) Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting. Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced. Timelines: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope. Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands scope of work and has an awareness of contract and budget assumptions. Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed. Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations. Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols. Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review. Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses. Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients. Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician. Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration. Qualifications Bachelors Degree Biostatistics or related field and 3 - 5 years relevant experience Req Or Masters Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience. Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative. Strong organizing skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as nQuery. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).