Job Title: Principal Non-Clinical Biostatistician
Location: Hyderabad
Join Sanofi, a leading global healthcare company dedicated to transforming the lives of millions. As a Principal Non-Clinical Biostatistician, you will play a key role in advancing our innovative work, leading statistical activities for Non-Clinical efficacy, safety studies, and CMC activities with minimal supervision from the statistical team leader.
Statistical Support: Contribute to the scientific quality and reliability of projects from target identification to process development by providing essential Non-Clinical statistical support.
Deliverables Accountability: Be responsible for all statistical deliverables related to one or multiple studies or activities in the Non-Clinical development area.
Data Analysis: Perform statistical analyses on laboratory data using R and possibly other programming languages (SAS, etc.), as well as standard statistical software (JMP, SIMCA, and internal tools), to produce statistical reports and memos.
Review and Optimize: Review study plans (randomization, sample size, analysis) and reports for both internal and external studies, ensuring alignment with Sanofi best practices.
Tool Development: Contribute to the development and support of statistical end-user tools, primarily using RShiny.
Methodology Advancement: Participate in internal working groups to develop state-of-the-art methodologies and statistical approaches.
Design and Sample Size Determination: Determine optimal design and sample size, particularly for in vivo experiments, in line with Animal Welfare Committee (AWC) requirements.
Collaboration: Ensure productive collaboration with cross-functional teams and effectively communicate results to senior leadership, promoting teamwork, quality, and innovation.
Representation: Represent statistics in scientific or technology working groups and cross-functional initiatives.
Experience: Background in the pharmaceutical or related industry with strong expertise in non-clinical statistics for biopharmaceutical development.
Statistical Proficiency: Proven experience in descriptive and inferential statistics, statistical process control, design of experiments, and multivariate data analysis (PCA, PLS, and related methods).
Technical Skills: Proficient in advanced statistical analyses using SAS, R, and other languages; familiarity with CMC regulatory guidelines (EMA, FDA, ICH Quality) and QbD principles.
Education: MS or PhD in Statistics or a relevant field.
Language Skills: Excellent communication skills in English, both oral and written.
Supportive Environment: Work alongside a dedicated team focused on making miracles happen through science.
Career Growth: Explore countless opportunities for advancement, whether through promotions or lateral moves, both locally and internationally.
Comprehensive Benefits: Enjoy a thoughtful rewards package that recognizes your contributions and supports your well-being, including high-quality healthcare and at least 14 weeks of gender-neutral parental leave.
Inclusive Culture: At Sanofi, we celebrate diversity and are committed to providing equal opportunities to all, regardless of background or identity.
Progress is driven by diverse teams united by a desire to innovate and make a difference. If you're ready to embrace new ideas and explore the opportunities we offer, let’s discover extraordinary together.
For more information on our diversity, equity, and inclusion initiatives, visit sanofi.com.
Watch "One Day at Sanofi" to see our culture in action.
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