Principal Scientist - CMC Statistician

BioSpace; Framingham (MA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Parental leave

Job summary

Sanofi in Framingham, MA seeks a Principal Scientist - CMC Statistician to lead statistical support across CMC process development, analytical methods, and formulation development. You will design experiments, analyze results, and prepare regulatory-ready reports.

Proficiency in R, SAS, Python, and JMP is required, with experience in regulatory submissions and cross-site collaboration. This role emphasizes methodological innovation and knowledge sharing within the team.

Qualifications

• PhD in Statistics or related field or a Master’s degree with strong statistical background.
• Experience in CMC (Chemistry, Manufacturing and Control) studies preferred.
• Proven ability to design, analyze and interpret complex studies for regulatory purposes.

Responsibilities

• Provide statistical support to CMC scientists for process development with emphasis on reliability and statistical 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 statistical tools.

Skills

DoE

Multivariate analysis

Statistical modeling

R

SAS

Python

JMP

Data analysis

Communication

Education

PhD in Statistics

Master's in Statistics

Tools

R

SAS

Python

JMP

SIMCA

MODDE

Job description

Job Title: Principal Scientist - CMC Statistician

Location: Framingham, MA

About The Job

As part of the development of Sanofis 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, youll be supporting the CMC activities for process, analytical methods and formulation development, for several CMC sites in the world.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

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 its 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff…? All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.