Job Title: Principal Non-Clinical Biostatistician
Location: Hyderabad, India
Job Type: Permanent, Full-time
At Sanofi, we are dedicated to improving lives through innovation, and as a Principal Non-Clinical Biostatistician, you will play a key role in supporting statistical activities for Non-Clinical efficacy, safety studies, and CMC activities. This role requires strong leadership in statistical analysis, as well as collaboration with cross-functional teams to optimize project support from target identification to process development.
Sanofi is a global healthcare leader committed to scientific excellence and providing opportunities for career growth and development in a supportive, dynamic environment.
Statistical Support: Provide statistical expertise for Non-Clinical development studies, including safety, efficacy, and CMC activities, ensuring all deliverables are met to the highest standards.
Data Analysis: Perform statistical analyses on laboratory data using tools like R, SAS, JMP, SIMCA, and other internal software, delivering clear statistical reports and memos.
Study Design: Review and contribute to the development of study plans (randomization, sample size, analysis) and reports for internal or external studies, ensuring adherence to best practices.
Statistical Tools Development: Contribute to the creation and support of statistical end-user tools, particularly using RShiny.
Methodology Contribution: Participate in internal working groups, helping develop state-of-the-art methodologies and statistical approaches for Non-Clinical development.
Optimal Design and Sample Size: Determine optimal design and sample sizes for in vivo experiments, with a particular focus on Animal Welfare Committee (AWC) considerations.
Cross-Functional Collaboration: Foster effective collaboration across teams, ensuring quality, innovation, and operational efficiency in all aspects of the statistical work.
Regulatory Support: Contribute to preparing statistical analyses for regulatory dossiers, ensuring alignment with CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias).
Presentation of Results: Present statistical findings to project team members and senior leadership, contributing to key decision-making processes.
Experience:
Soft and Technical Skills:
Education:
Languages:
Apply now to be a part of a dynamic, forward-thinking team and contribute to the future of healthcare!
At Sanofi, we are dedicated to creating a diverse and inclusive workplace. Learn more about our Diversity, Equity, and Inclusion initiatives.
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Ranchi |Karnataka :
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Remote - Europe | Remote | Remote, USA | Switzerland | Remote - Middle East |Bucharest :
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