Principal Scientist, CMC Statistics — AI-Driven Biopharma

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

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.