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Principal Scientist - CMC Statistician - Sanofi
Software Engineer
Principal Scientist – CMC Statistician leading statistical modeling, data analysis, and regulatory support for pharmaceutical CMC processes using SAS, R, and Python.
About the role
Key Responsibilities
- Develop and validate statistical models for process, analytical, and formulation data to support CMC activities across global sites.
- Lead Design of Experiments (DoE) studies, analyze results, and translate findings into actionable process improvements.
- Prepare statistical sections for new product registration dossiers, ensuring compliance with regulatory guidelines.
- Collaborate with cross‑functional teams to integrate digital tools and advanced analytics into CMC workflows.
- Provide expert statistical consultation during product development, scale‑up, and change control initiatives.
Requirements
- Ph.D. or Master’s in Statistics, Biostatistics, or related field with extensive experience in pharmaceutical CMC.
- Proficiency in SAS, R, and Python for data manipulation, modeling, and reporting.
- Strong background in Design of Experiments, statistical process control, and regulatory submission processes.
- Excellent communication skills and ability to translate complex statistical concepts to non‑technical stakeholders.
- Experience with digitalization initiatives and advanced analytics in a regulated environment is a plus.