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.

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

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.