Biostatistician Principal Scientist - CMC Statistics

Biostatistician Principal Scientist - CMC Statistics

Sanofi

Montpellier, France

About the job

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.

Main responsibilities

In close collaboration with Statistical Project Leader and/or Group Head:

• 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

About you

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