Biostatistician principal scientist – CMC Statistics Full-time

Biostatistician Principal Scientist – CMC Statistics

As Biostatistician Principal Scientist within our CMC Statistics team, you'll provide methodological and statistical support for multiple Chemistry Manufacturing and Control (CMC) projects, acting as a statistical expert within project teams. Ready to get started?

This is an exceptional opportunity to shape the statistical strategy for CMC development programs across our portfolio. You'll drive innovation in analytical method development, process optimization, and manufacturing excellence while ensuring robust statistical approaches support regulatory submissions. Your expertise will directly impact the quality and reliability of medicines and vaccines that reach patients worldwide.

About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

• Statistical expertise – Provide high-quality statistical support to CMC customers locally and remotely and advise on experimental designs and data analysis
• Statistical analyses – Perform data analyses using R and other tools (JMP, SIMCA, SAS) to produce reports and presentations
• Regulatory study design – Manage statistical aspects of complex or critical studies intended for regulatory submissions in alignment internal policies and external guidelines
• CMC interface – Act as the statistical point of contact for CMC-related functions and customers
• Promotion of statistical culture – Train scientists in statistical applications and promote statistical thinking in laboratories
• Cross-functional collaboration – Participate in technical working groups and statistician networks to harmonize practices, develop new statistical approaches and promote innovation
• Project leadership – Work independently as a statistical lead in cross-functional teams and represent statistics in multidisciplinary initiatives

Experience:

• 8+ years (MS) or 5+ years (PhD) in pharmaceutical area as statistician in process development, focusing on analytical method validation, product development, and quality assurance, ensuring state of the art quality and productivity. Strong background in statistical support for analytical method development, process characterization, and manufacturing. Experience with regulatory submissions and interactions with health authorities

Technical skills and soft skills:

• Statistical expertise: Robust knowledge in non-clinical statistics (ex: Model qualification, Specifications limits calculation, Stability studies, analytical methods transfer), industrial statistics (ex: descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), and statistical modeling/simulation
• Process improvement skills: Experience in applying statistics to enhance biologics or synthetics processes, including modeling and monitoring
• Technical proficiency: Skilled in statistical applications (R/RShiny, SAS, JMP, SIMCA, MODDE) and ability to work in high-compute, cloud-based environments
• Regulatory knowledge: Understanding of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias) with knowledge in GMP quality concepts (including QbD) used in pharmaceutical process development and production, and ability to prepare statistical analyses for regulatory dossiers
• Communication and teamwork: Strong interpersonal and communication skills for effective collaboration and networking with Experience in reporting and communicating plans, results, and conclusions in the form of technical documents and presentations
• Scientific rigor and independence: Demonstrated ability to run statistical work packages, develop and lead implementation of new technologies to solve problems

Education:

• MS or PhD in Statistics or relevant discipline

Languages:

• Excellent communication in English, both oral and written

Why Choose Us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
• Help improve the lives of millions of people globally by making drug development quicker and more effective
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice
• Achieve genuine work-life balance in a supportive R&D environment
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive

Pursue Progress. Discover Extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.