Job Title: Principal Scientist - CMC Statistician
Location: Framingham, MA
About the jobAs 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.
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 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
Why Choose Us- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
North America Applicants Only
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
