Principal Scientist - CMC Statistician

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

Basic Qualifications:
- PhD in Statistics/CMC/Industrial Statistics/Applied Mathematics/Data Science/Computational Biology/Bioinformatics or related field; OR Master’s degree in any of the above fields
- Minimum 3 years (PhD) or 6 years (Master’s) as a Statistician in CMC/industrial statistics/manufacturing (industry preferred); academic/research experience may be considered
- Knowledge of non-clinical statistics applied to CMC (e.g., method validation/transfer, specification limits, stability modeling, comparability, QbD)
- Expertise in industrial statistics including DoE, multivariate data analysis, or statistical modeling
- Proficiency in R or JMP; SAS or Python is a plus
- Experience writing and communicating regulatory technical documents, reports, and presentations

Preferred Qualifications:
- Good knowledge of pharmaceutical development processes
- Experience with complex exploratory analyses and regulatory filing support/Health Authority questions
- Experience with linear/non-linear models, statistical tests, control charts, modeling, and related methods
- Ability to run advanced analyses in departmental computing environments (e.g., R/RShiny, SAS, Python, JMP, SIMCA, MODDE)
- Strong interpersonal/communication skills; scientific rigor and independence
- Excellent understanding of CMC/GMP quality concepts and CMC regulatory guidelines (EMA/FDA/ICH Quality/Pharmacopoeias) and ability to prepare regulatory dossier analyses

Benefits (as stated): At least 14 weeks’ gender-neutral parental leave; healthcare and wellbeing benefits.

Application instructions: Not provided in the text.