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…