Principal Scientist - CMC Statistician

Sanofi•Framingham, MA

4d•$122,250 - $176,583•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

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

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