Principal Scientist - CMC Statistician

Job Title: Principal Scientist - CMC Statistician

Location: Framingham, MA

About the job

As part of the development of Sanofi’s pharmaceutical products, the R&D Data Sciences department and more specifically the Statistics department for the Chemical Manufacturing Control (CMC) ,CMC Statistics , is responsible for contributing to statistical support, modelling, digitalization, decision-making and filing of new product registration files.

As a CMC Statistician within our Data Sciences/CMC Statistics, you’ll be supporting the CMC activities for process, analytical methods and formulation development, for several CMC sites in the world.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

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:

• Provide statistical support to CMC scientists for process development, ensuring reliability and scientific quality

• Deliver statistical expertise for experimental design, data analysis, and interpretation of results

• Perform statistical analyses using R, SAS, Python, JMP, SIMCA, Modde, and other Sanofi statistical tools

• Prepare statistical reports, memos, and presentations for project teams and stakeholders

• Design and analyze complex or critical studies intended for Health Authorities

• Write statistical study reports in compliance with internal policies, external guidelines, and regulatory standards

• Serve as the CMC statistics contact and local interface between the CMC Statistics group and related functions

• Promote statistical thinking and culture within laboratories through training on methodology and tools

• • Support and train customers on validated statistical applications and methodologies

• Develop state-of-the-art statistical methodologies and participate in internal technical working groups and statistician networks

About you

Basic Qualifications:

Education:

• PhD in Statistics, CMC Statistics, Industrial Statistics, Applied Mathematics, Data Science, Computational Biology, Bioinformatics, or related scientific field.

• OR Master's degree in any of the above fields.

Experience:

• Minimum 3 years (PhD) or 6 years (Master's) of experience as a Statistician in CMC (Chemistry, Manufacturing and Control) studies/activities, industrial statistics, manufacturing, or closely related fields such as cosmetics or food industry. Academic or research experience may be considered but industry experience is preferred

• Knowledge in non-clinical statistics applied to CMC development (e.g., analytical method validation or transfer, specification limits calculation, stability modeling, comparability studies, or Quality by Design)

• Expertise in industrial statistics including Design of Experiments (DoE), multivariate data analysis, or statistical modeling

• Proficiency in statistical software applications, such as R or JMP; experience with SAS or Python is a plus

• Experience in writing and communicating technical documents, reports, and presentations for regulatory purposes

Preferred Qualifications:

• Good knowledge of pharmaceutical development processes

• Experience in performing complex exploratory statistical analyses

• Experience in supporting analyses for regulatory filings and addressing Health Authority questions

• Experience with statistical science applications, such as linear/non-linear models, design of experiments (DoE), statistical tests, multivariate analysis, control charts, modeling, etc.

• Able to work in a departmental computing environment and perform advanced statistical analyses using programming code such as R/RShiny, SAS, Python, or statistical software such as JMP, SIMCA, MODDE

• Demonstrate interpersonal and communication skills necessary for effective teamwork

• Scientific rigor and demonstrated level of independence to run statistical work packages

• Contribute to developing state-of-the-art methodologies and statistical approaches on a variety of subjects needed for his/her field(s) of expertise, in partnership with other statisticians from the team and other groups of statisticians when appropriate. Participate in internal technical working groups and networks of statisticians

• Excellent understanding of processes associated with CMC and GMP quality concepts used in pharmaceutical development and production

• Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopoeias), QbD principles, and ability to prepare statistical analyses for regulatory dossiers

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• 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.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.