Principal Scientist - CMC Statistician

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

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.

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