224 Biostatistics Jobs - Page 7

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.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

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 Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. 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 Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, 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 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment. Show more Show less

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 Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. 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 Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, 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 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment. Show more Show less

Company Description AlzaSyno Life Sciences offers a comprehensive suite of CRO (Contract Research Organization) services tailored to the pharmaceutical, bio-pharmaceutical, medical device, and Ayurvedic sectors. Their key services include Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory Affairs. Role Description This is a full-time on-site role for a Quality Assurance Executive located in Gurgaon. The Quality Assurance Executive will be responsible for implementing and maintaining quality standards, conducting quality audits, and managing quality control processes on a day-to-day basis. Qualifications Quality Control and Quality Assurance skills in Clinical Trial Quality Management and Quality Auditing skills in Clinical Trial Strong attention to detail and analytical skills Knowledge of regulatory requirements and compliance in Clinical Trial Excellent communication and teamwork skills Bachelor's degree in Life Sciences, Chemistry, Biology, or related field Show more Show less

Job Description As a Software Engineer, the person will contribute to the development of product software. Depending upon the project need, the person may develop front- or back-ends of rich, interactive cloud-native apps, interactive dashboards and visualizations for data-intensive scientific apps, rich desktop apps. Responsibilities Study and understand the software requirements and participate actively in requirements discussions. Develop and execute automated unit tests for your code, ensuring adequate code coverage. Address code review comments in a timely manner. Troubleshoot, debug and fix defects in the application. Document code as per the standard process, and support tech leads in your code’s integration with other parts of the application. Identify and list opportunities for code refactoring and share those with your tech leads. Estimate and plan your own work and deliver as per the plan. Work within an Agile Scrum team by collaborating with tech leads, Subject Matter Experts, and other team members. Master relevant software development practices, tools, and technologies. Comply with relevant company policies. Keep knowledge up to date by undergoing appropriate trainings and courses. Develop requirements by following the approved design, coding guidelines, and coding standards. Familiarize yourself with Cytel’s values and competencies required to succeed in your job and incorporate in your work. Qualifications Bachelor’s or Master’s degree in Computer Science & Engineering (CSE) or equivalent STEM degree are preferred; however, candidates from other disciplines with relevant skills and competencies may also be considered. Experience And Skills 0-2 years of experience in developing desktop apps or web apps Knowledge of programming in Python preferred Knowledge of web development using C#.net, HTML, CSS, JavaScript, React preferred Good to have: Basic knowledge of databases (e.g., PostgreSQL) Quick learner with strong numerical & verbal aptitude, logical reasoning, and analytical ability Self-driven with the ability to think creatively and solve complex problems. Strong verbal and written English communication skills Collaborative mindset Experience working in Agile teams and knowledge of frameworks like Scrum About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Show more Show less

Job Description As a Software Engineer, the person will contribute to the development of product software. Depending upon the project need, the person may develop front- or back-ends of rich, interactive cloud-native apps, interactive dashboards and visualizations for data-intensive scientific apps, rich desktop apps. Responsibilities Study and understand the software requirements and participate actively in requirements discussions. Develop and execute automated unit tests for your code, ensuring adequate code coverage. Address code review comments in a timely manner. Troubleshoot, debug and fix defects in the application. Document code as per the standard process, and support tech leads in your code’s integration with other parts of the application. Identify and list opportunities for code refactoring and share those with your tech leads. Estimate and plan your own work and deliver as per the plan. Work within an Agile Scrum team by collaborating with tech leads, Subject Matter Experts, and other team members. Master relevant software development practices, tools, and technologies. Comply with relevant company policies. Keep knowledge up to date by undergoing appropriate trainings and courses. Develop requirements by following the approved design, coding guidelines, and coding standards. Familiarize yourself with Cytel’s values and competencies required to succeed in your job and incorporate in your work. Qualifications Bachelor’s or Master’s degree in Computer Science & Engineering (CSE) or equivalent STEM degree are preferred; however, candidates from other disciplines with relevant skills and competencies may also be considered. Experience And Skills 0-2 years of experience in developing desktop apps or web apps Knowledge of programming in Python preferred Knowledge of web development using C#.net, HTML, CSS, JavaScript, React preferred Good to have: Basic knowledge of databases (e.g., PostgreSQL) Quick learner with strong numerical & verbal aptitude, logical reasoning, and analytical ability Self-driven with the ability to think creatively and solve complex problems. Strong verbal and written English communication skills Collaborative mindset Experience working in Agile teams and knowledge of frameworks like Scrum About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Job Info Job Identification 775 Job Category Software Engineering Posting Date 05/30/2025, 06:47 AM Locations 5th Floor, Lohia-Jain IT Park, Pune, Maharashtra, 411038, IN Apply Before 06/01/2025, 12:00 PM Job Schedule Full time Show more Show less

Job Description Position: Medical Coder - Work from Home Ct: HR KAMATCHI - 8925264660 Job Description:Medical Coding is the process of conversion of text information related to healthcare services into numeric Diagnosis (Medical Problems) and Procedure (Treatments) Codes using ICD-10 CM and CPT code books. Requirement knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills No of vacancy: 500 Eligibility Nursing GNM/DGNM Life science graduates Pharmacy Physician assistant Bio medical Engineers Bio chemistry Bio technology Bio informatics Micro biology Zoology and Advanced zoology Biology Botany Plant biotechnology Genetics Food and Nutrition Paramedical Physiotherapy M.Sc. Clinical Nutrition M.Sc. Human Genetics M.Sc. Medical Laboratory Technology M.Sc. Medical Sociology M.Sc. Epidemiology M.Sc. Molecular Virology M.Sc. Biostatistics M.Sc. Blood Banking Technology M.Sc. Rgnerative Medicine M.Optom. M.Sc. Genetic Counseling M.Sc. Radiolog Imaging Technology M.Sc. Medical Biochemistry M.Sc, Medical Microbiology M.Sc. Clinical Care Technology M.Sc. Clinical Care Technology M.Sc. Medical Physics B.Sc. - Accident Emergency Care Technology B.Sc. - Audiology speech Language Pathology B.Sc. - Cardiac Technology B.Sc. - Cardio Pulmonary Perfusion Care Technology B.Sc. - Critical Care Technology B.Sc. - Dialysis Technology B.Sc. - Neuro Electrophysiology B.Sc. - M.L.T. B.Sc. - Medical Sociology B.Sc. - Nuclear Medicine Technology B.Sc. - Operation Theatre Anaesthesia Technology Bachelor of Science in Optometry B.Sc. - Physician Assistant B.Sc. - Radiology Imaging Technology B.Sc. - Radiotherapy Technology B.Sc. - Medical Record Science B.Sc. - Respiratory Therapy B.Sc. - 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 Salary 15K to 17K (fresher) To 50K (experienced) Pm (Incentives Benefits as per Corporate Standards) 4K fixed hike after six months Other Benefit Pick Up Drop Facility Food Facility Day Shift Weekend Off Reach Us HR KAMATCHI 8925264660 Required Candidate profile Nursing Freshers Pharmacy Freshers Physiotherapy Dentist Life sciences Biotechnology Microbiology Biomedical Biochemistry Bioinformatics Botany Zoology GNM DGNM Physician assistant Anesthesia technician Perfusion Technology Medical coder Freshers Medical coding Freshers jobs in chennai Medical coding openings in chennai Wanted Medical coder Freshers jobs Medical coding Medical coder Medical coding Freshers Jobs in chennai Jobs for Passed outs Freshers jobs in chennai Jobs for freshers Nursing jobs for freshers Pharma jobs for Freshers Biotechology Jobs Microbiology jobs Biomedical jobs Bioinformatics jobs Bsc/Msc Jobs Biochemistry jobs Life science jobs in chennai Paramedical jobs in chennai Jobs in Tamilnadu Jobs in Pharmacy Jobs in Hospital Perks and Benefits Incentives Benefits as per Corporate Standards This job is provided by Shine.com Show more Show less

Job Description Step into the role of Executive Director, Head of Business Intelligence & Offshore Analytics, and lead our offshore team in shaping the future of our Business Banking business. You'll be responsible for all aspects of our Business Intelligence and production reporting, managing analytics and data resources, and implementing BI/reporting, analytics, AI/ML, and data strategies. With your strong analytical skills and expertise in financial services, you'll tackle complex problems, develop innovative solutions, and make a significant impact on our business. As an Executive Director, Head of Business Intelligence & Offshore Analytics within our Business Banking team, you will be responsible for leading customer-centric development, inspiring innovative solutions, and shaping the future with your strategic vision. Your role will involve leading our offshore team and managing all aspects of our Business Intelligence and production reporting for Business Banking stakeholders. This position requires a blend of consultation and leadership in the development and implementation of BI/reporting, analytics, AI/ML, and data strategies throughout our Business Banking business. You will be tasked with solving complex problems that lack defined solutions, requiring your team to assess and understand the situation, then develop BI/reporting, analytics, AI/ML, and data solutions to proactively address it. Job Responsibilities Develop and support innovative BI/reporting, analytics, data strategies and AI/ML for Business Banking that will leverage new and existing data sources related to customers, products, accounts, transactions, channels. Manage all Business Intelligence and reoccurring reporting that supports Controls, Products, Marketing, Sales and CAO stakeholders Interface directly with senior executives in Product, Sales, Marketing, Controls, Finance, Strategy, and Data & Analytics teams across the organization Solve key business problems by leading the practical application of BI/data visualization, data sciences/analytics, and data design efforts Mentor, develop, and lead our Offshore team of talented advanced analytics, BI, and data professionals Understand client’s business challenges to efficiently structure practical solutions that create favorable business impact Develop AI/ML/LLM solutions to support use cases to support our BB clients and D&A needs Innovate with the customer and business impact in mind Partner with with multiple business partners, clients, and senior executives skillfully and communicate with them at their level of analytical/technical understanding Required Qualifications, Capabilities, And Skills BS Degree in a quantitative field and 10+ years of producing and overseeing advanced BI and analytics work to include people management and development Global and US Financial Services experience to effective manage Offshore resources to support and own end-to-end functions, and enhance team integration with key stakeholders Experienced in the practical use of customer/account data, channel usage, and client profitability for analytics, segmentation, management insights, loan and product pricing, and sales management to drive market share growth and profitability improvements Seasoned Analytics professional with broad knowledge of quantitative and analytical concepts, methods, tools, and technologies Proficiency in data analysis languages (i.e. Python, SAS, Java, R, JavaScript, C++, Scala) relational databases/tools (i.e. SQL, Teradata, Snowflake, Data Bricks), and BI/Reporting tools (i.e. Tableau, Alteryx, etc) Experience with Public and Private Cloud platforms such as AWS, Azure, etc. Robust technical experience in data extraction, transformation, and load (ETL) processing Hands-on experience in delivering BI/reporting, analytics and insights to multiple levels of management supporting Product, Strategy, Finance, and Sales Demonstrates well-rounded skills in a variety of areas including: time series analysis, learning algorithms, dimensionality reduction, experimental design, A/B and multivariate testing, and matched pairs analytics Skilled at creating impactful presentations in a consultative and influential manner at the executive level Strong controls mindset and experience Preferred Qualifications, Capabilities, And Skills MBA, Master's, or PhD in a quantitative field preferred: Statistics, Applied Mathematics, Computing and Information Theory, Econometrics, Biostatistics, Operations Research, or Industrial / Electrical Engineering Financial Service industry experience desired, but we are open to evaluating candidates with strong analytics backgrounds from other industries Strong knowledge of Consumer/Wealth/Investment/Small Business products and services, including deposits, lending, cash management, investments, credit cards and merchant services Strong Management experience, including teams that are located offshore ABOUT US JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world’s most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation. About The Team Our Consumer & Community Banking division serves our Chase customers through a range of financial services, including personal banking, credit cards, mortgages, auto financing, investment advice, small business loans and payment processing. We’re proud to lead the U.S. in credit card sales and deposit growth and have the most-used digital solutions – all while ranking first in customer satisfaction. Show more Show less

Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. Discover Impactful Work: Discover Impactful Work:Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. A day in the Life: Coordinates and reviews safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Identifies potential issues and resolves or escalates as appropriate Reviews safety data and may provide summations for safety review meetings. May review designated sections of aggregate reports. May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested. May help Manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations. Monitors the status of the data review and escalates any delays and/or risks to all stakeholders, including study leads. May present at business development, client, and investigator meetings and participate in strategy/business development calls. Resolves complex problems through in-depth evaluation of various factors and offers solutions. May serve as the primary point of contact for clinical/data management project teams. May assist management in training and mentoring. Keys to Success: Education Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance) Knowledge, Skills, Abilities Knowledge of GCPs for medical oversight of clinical trials and SAE processing Knowledge of drug development and safety reporting Knowledge of safety data trending to include coding Working knowledge of biostatistics, data management and clinical procedures Strong problem solving and critical thinking skills Good oral and written communication skills Good Strong attention to detail Ability to work in a collaborative team environment Ability to maintain a positive and professional demeanor in challenging circumstances Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) Show more Show less

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 291 b) To Apply for above Job Role ( Pune ) Type : Job Code # 292

Statistical Programmer – L2 Job Summary: Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1) , is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities: Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education and Work Experience: Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities: Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.

Description Statistical Programmer – L2 Job Summary Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1), is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education And Work Experience Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com. Show more Show less

KMK is a global data analytics and technology consulting company empowering leaders across the Life Sciences industries to make better data-driven decisions. Our data analytics and software platforms support data science, commercial operations, real world evidence, and cloud information management. We help to optimize business strategy and operations by delivering cutting edge analytics from the broadest set of data sources, combined with deep technical and domain expertise. We enable commercial excellence delivering analytical guidance to the field through SalesOps™, our cloud-based sales planning and operations platform. We are leaders in managing data using the latest cloud information management and big data technologies. We have more than 180 employees worldwide, are growing rapidly, and are proud to count a number of the top 10 global Life Sciences companies as our customers. We serve clients with a high-touch on-site and onshore presence, leveraged by a global delivery platform. Job Overview: We are currently seeking an experienced Health Economics & Outcomes Research (HE&OR) Associate. This position is responsible for the scientific and methodological aspects of all observational database analytics and evidence synthesis with minimal supervision. Job Description Provide consultation on all aspects of internal RWE databases studies/analyses including objectives, study design, data source identification, protocol development, statistical analysis and interpretation. Execute RWE studies/analyses by SAS based on claim database, EMR database, registry data and public used files. Generate high quality, readily interpretable deliverables (e.g., data tables, graphs, charts, study reports). Develop mock table shells, prepare specifications, and ensure quality control on analyses conducted by junior programmers. Effective manage and track all studies/analyses to ensure timelines are met and all stakeholders aware of project status. Effectively communicate research findings internally and externally, as appropriate (e.g., congresses, publications) Ensure latest methodologies and analytical techniques are implemented. Contribute to the continuing education of relevant line functions on RWE methodologies. Requirements Minimum MS in statistics, biostatistics, epidemiology, health economics and outcomes research, health policy, or similar. At least 2 years’ hands-on experience in observational data studies. Professional programming skills with SAS. SQL and R programming experience are plus. Excellent interpersonal communication and study management skills. Ability to take detailed HE&OR study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings. Ability to work effectively in a constantly changing, diverse, and matrix environment. Ability to proactively identify new opportunities and solutions Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel) Qualifications: Positive attitude/interested: Good candidates care about the result and how the result be used. They are willing to spend more time to explore more in addition to what is requested. They are able to readily take ownership of responsibilities Good problem-solving/critical thinking skills: Good candidates are able to understand problems clearly. They ask the right questions, break problems down into hypotheses and propose solutions in a coherent manner. Solid programming and analytical skills: Good candidates demonstrate competence in the application of statistical techniques and professional in programming which includes good programming habit and self-QC process. Good communication skills: Good candidates are able to take detailed study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings. Great at time and task management: Good candidates are able to estimate the amount of time needed to complete a task, communicate this to client clearly and deliver it on time. Quick learning capability/Self-motivated: Good candidates have the ability to learn new technologies on their own. Good team player Technical requirements: Preferred MS in statistics, biostatistics, epidemiology, computer science, or other quantitative analysis fields. Demonstrated competence in the application of statistical techniques, such as hypothesis testing, regression analysis, machine learning, etc.. Professional programming skills with SAS and SQL. R and/or Python programming experience is plus. Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel). About KMK consulting Inc KMK Consulting brings together a range of functional competencies in marketing science, market research, forecasting and sales force effectiveness to provide our biopharma clients with fully integrated solutions that support their commercial success. Show more Show less

About ICBio Clinical Research Pvt. Ltd.: Headquartered in Bengaluru, India, ICBio is a full-service Contract Research Organization (CRO) with over 16 years of experience in conducting Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. We have successfully completed over 1,000 BA/BE studies and approximately 500 clinical trials. Our services are approved by several global regulatory bodies, including ANVISA Brazil, DCGI, CDSCO, MHRA, UAE MOH, GCC, MOH Kazakhstan, and Zambia . Our NABL-accredited central laboratory is fully integrated with LIMS, ensuring high-quality data and compliance. Our Services Include: Bioavailability/Bioequivalence Studies Phase I–IV Clinical Trials Bioanalytical Services Regulatory Affairs and Dossier Preparation Pharmacovigilance Clinical Data Management and Biostatistics Medical Writing job responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOP’s are available in work place. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Ensure computerized systems used in the studies has been validated as per the regulatory requirement. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. Approve the individual sample repeats, ISR and investigation of batch failures. In case of any deviation from the protocol, assess and document the impact on the quality and integrity of the study and take appropriate corrective action when necessary. Ensure regular instruments backup and study related documents are archived properly. Show more Show less

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

🚨 We’re Hiring | Research Associate – Computational Oncology & Single-Cell Genomics Project Title: Tumor Grade Progression & Drug Discovery in ccRCC Using Single-Cell Multi-Omics 📍 Location: NIT Rourkela, Odisha, India (On-site) 🗓️ Apply by: June 24, 2025 | 💻 Interview: Online 💼 Type: Full-time | ⏳ Duration: 3 years 💰 Salary: ₹69,600/month (₹8.35 LPA) Join Dr. Akhilesh Mishra’s lab at NIT Rourkela on an ANRF-funded project exploring tumor heterogeneity and novel drug targets using cutting-edge single-cell genomics and computational oncology . 🔍 What You’ll Do Perform NGS data analysis and Single Cell Genomics studies. Collect & classify clinical ccRCC samples with pathologists 🎓 Who We’re Looking For Required: Ph.D. in Computational Biology, Bioinformatics, Computer Science, or related field OR PG degree + 3 years of experience in NGS/Computational Biology + 1 SCI publication Preferred: Experience with NGS Data Analysis and single-cell genomics Proficiency in biostatistics, data analysis, and biomedical techniques 🧠 About the Lab Dr. Mishra’s lab works at the intersection of genomics, systems biology, and AI. His work has been featured in PNAS, JCI, European Urology, and NAR . This is a dynamic opportunity to grow under strong mentorship while contributing to impactful cancer research. 📩 How to Apply Send a completed application form, CV, and publications (as one PDF) to: 📧 mishraakhilesh@nitrkl.ac.in , akhilesh.bioinfo@gmail.com Subject: Application for RA Position – NITR/SR/2025/Advt. - 25LS010 No hard copies required. Show more Show less

Description Medical Writer II (CSR Narrative) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Annual reports; Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications What we’re looking for Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Medical Writer II (CSR Narrative) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Annual reports; Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications What we’re looking for Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Senior Biostatistician Location: Chennai, India (Hybrid/Remote options available) Department: Biostatistics About the Company A well-established, full-service CRO with over three decades of experience supporting statistical analyses and programming across all phases of drug development. The Biostatistics Division is recognized for its scientific integrity, quality deliverables, and timely execution. Role Overview The organization is seeking an experienced Senior Biostatistician to lead statistical activities in clinical trials. This individual will uphold high standards of scientific rigor and ensure regulatory compliance while working closely with teams across clinical data management, programming, and medical writing. Key Responsibilities Contribute to study design and draft statistical sections of clinical trial protocols Perform sample size and power calculations; generate randomization schedules Develop and review Statistical Analysis Plans (SAPs) and table shells Conduct statistical programming to generate efficacy-related tables, listings, and figures Review statistical output for accuracy and completeness Conduct literature reviews to support statistical methods Ensure adherence to internal guidelines and external regulatory standards Participate in client and regulatory audits Contribute to interpreting clinical trial results and assess clinical relevance Collaborate with cross-functional teams throughout the project lifecycle Qualifications Master’s or Ph.D. in Biostatistics, Statistics, or related field At least 5 years of experience in clinical trial biostatistics within a CRO or pharma environment Proficient in SAS and/or R Strong understanding of statistical methodologies including linear regression, survival analysis, and Bayesian approaches Experience analyzing and interpreting clinical data Familiarity with statistical analysis plans and research study design Excellent analytical and problem-solving abilities High attention to detail and accuracy Strong communication skills, with the ability to explain complex statistical concepts to varied audiences Capable of working independently and in a team setting Preferred Skills Experience with CDISC standards (SDTM, ADaM) Knowledge of regulatory guidelines (FDA, EMA, ICH) Strong interpersonal and project management skills Experience mentoring junior statisticians and contributing to SOPs, templates, or standards Show more Show less

This Job is based in Australia Employment Type: Full Time, 35 hours per week Duration: 12 months fixed term Remuneration: Level A Academic $88,290 - $117,718 (based on experience) + 17% superannuation + leave loading Location: Kensington, New South Wales Visa sponsorship is not available for this position. Candidates must hold unrestricted work rights to be considered for this position. Why This Role Matters The Research Associate (Biostatistics) will contribute to the work of the Population Child Health research group within the School of Clinical Medicine at UNSW, supporting a multidisciplinary team committed to improving the health, wellbeing, and development of children and young people at local, national, and international levels. This role is central to enhancing research quality by providing expert statistical and epidemiological support, with the aim of increasing high-impact publication outputs and securing competitive grant funding. Working across the Sydney Children’s Hospitals Network, Local Health Districts, and with state and Commonwealth government partners, the Research Associate will support innovative, translational research that informs service delivery, clinical practice, and health policy. The successful candidate will contribute to the design, analysis, and reporting of intervention-based studies, and will also assist in developing grant proposals. A key aspect of the role includes the analysis of cohort and trial-related data, which will be beneficial in supporting robust and meaningful research outcomes. This position is well-suited for an individual with a strong foundation in biostatistics and epidemiology who is passionate about applying their skills to research that has a direct and lasting impact on child and adolescent health. The Research Associate reports directly to the Head of the Population Child Health research group and has no direct reports. Skills Required A PhD in Epidemiology/Statistics or related discipline, and/or an appropriate level of expertise gained from a combination of experience, training and/or professional accreditation. Competency in a range of statistical software, preferably R, SAS and/or Stata, and previous experience working with large sets of data. Experience working in the design and evaluation of trials would be beneficial Evidence of highly developed interpersonal skills and demonstrated ability to work in a team, collaborate across disciplines and build effective relationships with diverse stakeholders at all levels of seniority. Demonstrated ability to undertake high quality academic research (including study design and implementation, grant writing, and ethics applications) and conduct independent research with limited supervision through engaging organisational stills, managing priorities, and demonstrating attention to detail. Proven commitment to keeping up to date with discipline knowledge and developments. Demonstrated track record of publications and conference presentations relative to opportunity. An understanding of and commitment to UNSW’s aims, objectives and values in action, together with relevant policies and guidelines. Knowledge of health and safety responsibilities and commitment to attending relevant health and safety training. To learn more about this position, and view the comprehensive skills and criteria list, a copy of the Position Description can be found by clicking on the position description button beneath our ad on JOBS@UNSW. Specific Pre-Employment Checks Required Verification of qualifications Working with Children Check or the willingness to obtain one Criminal Records Check Benefits And Culture UNSW offer a competitive salary and access to a plethora of UNSW-perks including: 17% Superannuation and leave loading Flexible working Additional 3 days of leave over the Christmas Period Access to lifelong learning and career development Progressive HR practices More information on the great staff benefits and culture can be found here. How To Apply Please click Apply now to submit your application online. Applications submitted via email will not be accepted. Please provide a resume and a cover letter addressing the selection criteria (Skills and Experience in the position description) and interest in the role. Applications that do not address these selection criteria will not be considered. To view the full position description, please click on the Position Description link below. Contact : Aarti Talent Acquisition Coordinator a.aarti@unsw.edu.au Applications close: Wednesday 28th May before 11:30 pm UNSW is committed to evolving a culture that embraces equity and supports a diverse and inclusive community where everyone can participate fairly, in a safe and respectful environment. We welcome candidates from all backgrounds and encourage applications from people of diverse gender, sexual orientation, cultural and linguistic backgrounds, Aboriginal and Torres Strait Islander background, people with disability and those with caring and family responsibilities. UNSW provides workplace adjustments for people with disability, and access to flexible work options for eligible staff. The University reserves the right not to proceed with any appointment. Show more Show less

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Other duties as assigned. Necessary Skills And Abilities Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree or higher, preferably in medical or scientific discipline. Experience Requirements Minimum of 6 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case‑by‑case basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less

Select the apt sample size; collect data; perform the test; and develop TLG (tables, listings, and graphs); and finally, report the inference. Review of ADaM Specifications and TLGs. Develop statistical analysis plans (SAPs) in alignment with clinical protocols and regulatory guidelines (ICH, FDA, EMA). Perform and validate complex statistical analyses using SAS and R , ensuring accuracy and reproducibility. Provide statistical input into clinical study design, sample size calculation, randomization, and data collection strategies. Collaborate closely with Clinical, Data Management, Medical Writing, and Regulatory Affairs teams. Present and interpret statistical findings to non-technical stakeholders and contribute to publications or regulatory submissions (CSR, ISS/ISE, etc.). Lead or contribute to the development of standard operating procedures (SOPs), templates, and best practices. Mentor junior statisticians and provide peer review of statistical deliverables. Excellent written and verbal communication skills. Ability to manage multiple projects and priorities in a fast-paced environment. Location : Pan India Shift : General Shift

Job Brief State Program Manager, Maharashtra Vital Strategies India Services Private Limited, is a social enterprise focused on strengthening and revitalizing public health systems to address the leading causes of death, disease, and injury. We deploy our unique world-class technical expertise and global experience to design and support scalable solutions that can bridge the gap between public health needs and their solutions, focusing on rapid, large-scale impact. We leverage our core strengths in the areas of public health intelligence to strengthen the collection and use of data for informed government action, strategic communication to build awareness and behaviour change, institutional strengthening, and innovative financing. In addition to our topical areas of focus – noncommunicable diseases, environmental health and climate change, injury prevention, and social determinants of health we also prioritize work that aims to strengthen the fundamental, foundational dimensions of public health practice that enable governments to tackle and respond to any public health challenge. We welcome applications from people of all backgrounds and do not discriminate based on characteristics such as race, color, age, religion or creed, gender, national origin, ancestry, physical or mental disability, veteran or military status, marital status, or any other basis protected by country and local laws. We are proud of our commitment to a professional work environment where everyone is treated with respect and dignity. Vital Strategies India will not tolerate its employees, volunteers, consultants, partners, or any other representative associated with the delivery of its work carrying out any form of sexual harassment, sexual exploitation, or sexual abuse, and thoroughly vets all final candidates. About The Project In collaboration with Pure Earth, Vital Strategies is leading public health surveillance design and implementation, data collection and analysis, and health professional training for the “Realizing Children’s Full Potential by Ending Lead Poisoning” project. We are working with local partners in five locations, including Colombia, India (Maharashtra), Indonesia, Kyrgyzstan, and Peru to overcome key technical and clinical challenges and implement effective national/ state action to monitor and reduce lead poisoning risks. Job Purpose The State Program Manager, Maharashtra will provide technical support in enhancing the state health systems' capacity to reduce lead poisoning. The manager will offer epidemiological and programmatic support, including supporting the design, implementation, and monitoring of blood lead surveillance in the state. With technical support from the Vital Strategies team, the State Program Manager will use data to help the government plan, formulate, and enact sound local public health policies. The role involves collaborating with a team of environmental health scientists, epidemiologists, clinicians, public health professionals, statisticians, and partnering with high-level government officials. The position is grant-funded through December 2027 with the possibility of extension. Duties and Responsibilities: Technical and Programmatic Support: Collaborate with the team to provide technical support in the design and implementation of the lead poisoning prevention program in Maharashtra; Assist in guiding and building the capacity of government and non-government staff to implement the lead poisoning prevention program; Provide support in the development of a surveillance framework, standardizing surveillance procedures, and obtaining ethical approval; Train and monitor state, district, and field surveillance teams’ activities; Develop and deliver health-oriented content for workshops and training for local stakeholders or health professionals as needed. Stakeholder Management: Assist in developing and maintaining partnerships with government and non-government stakeholders across various sectors, including health, environment (such as pollution control board), academic and research institutions, etc; In collaboration with the supervisor, serve as a Vital Strategies focal point and representative for key state-level stakeholders. Data Management: Coordinate efforts across different departments to inventory relevant hazard, exposure, and demographic data; Lead a process for developing summary indicators, support data management, quality control, and visualization of indicator data in an integrated data store and visualization platform; With designated personnel, monitor data collection, ensure data quality, and manage data sets; Work with the supervisors and senior epidemiologists to clean, analyze, and report surveillance data ensuring the quality of surveillance data. Communication: Create presentations, technical reports, and non-technical summaries for varied audiences, including policy-makers and the general public; Disseminate and present report findings to stakeholders and promote data use for policy and planning. Operations and Program Administration: Support recruitment, contracting, and procurement activities; Coordinate and monitor the implementation of key project activities; Act as local Vital Strategies focal point and representative for key partner organizations in Maharashtra; Assist with other duties as specified by the supervisor. Qualification and Experience: Education Master’s degree in public health, epidemiology, environmental science, or related public health field (e.g., biostatistics, demography) or public administration, or MBBS. Experience Required Minimum six to seven years of relevant experience, of which at least 3 years should be at the state level; Experience in supporting the design and monitoring of health surveillance programs at the state level or previous experience managing large health-related surveys; Experience working with government health departments, regulatory bodies, and public health facilities; Experience supporting the implementation and monitoring of public health programs at the state level; Experience in designing, managing field data collection, analysis, and reporting; Experience in using data analytic software (e.g. R, Stata, SAS, Excel) and/or data visualization platforms (e.g., Shiny, Tableau); Experience in conducting training sessions; Preferred Experience managing complex data flows; Experience in communicating scientific and health information to varied audiences; Experience in using project management platforms such as Monday or Airtable is a plus. Skills And Abilities - Demonstrated familiarity with public health systems, health programs, disease surveillance programs, and health and environmental risk assessment; Understanding of advocacy for evidence-based interventions and how to navigate bureaucratic processes; Strong organizational skills, with the ability to manage competing priorities and deadlines. Ability to work independently while coordinating with diverse teams and stakeholders; Excellent verbal and written communication skills to convey technical information to diverse audiences. Ability to prepare reports and presentations for decision-makers; Professional oral and written proficiency in English, Hindi, and Marathi; Proven ability to interpret public health data, generate actionable insights, and support policy recommendations; Ability to anticipate challenges and identify obstacles, work with team to develop solutions, and remain flexible with shifting program needs; Passion for addressing environmental health challenges and improving community well-being; Solid knowledge of Microsoft Office suite; Ability to build strong, ongoing, impactful relationships at all organizational levels and across a diverse range of cultural, generational, ethnic, racial, educational, and social backgrounds; Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment. Working Conditions and Physical Requirements: Ability to work flexibly with colleagues across time zones Willing to travel for in-person meetings with government, partners, and relevant local stakeholders or visit field work as needed. Must be located in Pune, Maharashtra. Show more Show less

Statistician – Biosimilar Phase I Studies K3-Innovations is seeking a Statistician to lead the design and analysis of biosimilar clinical trials , focusing on Phase I trials including PK/PD equivalence , Bayesian methods , and regulatory strategy . Key Responsibilities: Design and analyze biosimilar Phase I trials (PK/PD, immunogenicity) Apply Bayesian modeling and adaptive design strategies Author SAPs, protocols, and study reports Develop Cutting Edg Trial Designs Present statistical designs and results to the FDA and other agencies 25% Travel to US Qualifications: Master’s/Ph.D. in Biostatistics or related field 8+ years in clinical trial statistics, including 5+ in biosimilars Expertise in Bayesian methods and equivalence study design Experience presenting at FDA meetings (e.g., Type B, Scientific Advice) Proficiency in R, SAS, Stan, JAGS, or WinBUGS Knowledge of FDA/EMA biosimilar and ICH guidance Show more Show less