Biostatistician principal scientist - cmc statistics

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Job title: Biostatistician principal scientist - CMC Statistics

* Location: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.

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

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


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.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

#LI-FRA

#LI-Hybrid

La diversité et l’inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu’apporte la diversité, Sanofi s’engage à donner l’exemple en matière d’inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.