Head of CMC Statistics & Analytics

Vertex Pharmaceuticals LLC; Boston, Northern (MA, KY); Hybrid; USD 193,000 - 290,000; Full time

Benefits offered by this job

Total rewards package

Hybrid / On-site flexibility

Commuting subsidy

Job summary

Vertex Pharmaceuticals LLC is seeking a CMC Statistics Director (Scientific Fellow) to provide strategic statistical leadership across the CMC lifecycle, influencing process development, manufacturing, quality, and regulatory submissions. You will establish the CMC Statistics Center of Excellence and drive data-driven decisions using DOE and advanced analytics.

The role requires a Ph.D. or MS in a quantitative field with extensive industry experience, and a strong track record in regulated

Qualifications

• Ph.D. with 10+ years of relevant industry experience or M.S. with 12+ years of relevant industry experience.
• Demonstrated experience supporting CMC development, process validation, manufacturing, quality operations, and regulatory submissions.
• Experience applying statistical methodologies across biologics, cell and gene therapy, small molecules, and/or combination products preferred.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead the CMC Statistics Center of Excellence with standards and governance.
• Support DPQ/PPQ, CPV, SPC, and process capability monitoring.
• Develop designs of experiments (DOE) for development and optimization.
• Author and defend statistical content for regulatory submissions.

Education

Ph.D. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or related quantitative discipline

M.S. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or related quantitative discipline

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Pharmaceuticals LLC is seeking a CMC Statistics Director (Scientific Fellow) to provide strategic statistical leadership across the CMC lifecycle, influencing process development, manufacturing, quality, and regulatory submissions. You will establish the CMC Statistics Center of Excellence and drive data-driven decisions using DOE and advanced analytics.

The role requires a Ph.D. or MS in a quantitative field with extensive industry experience, and a strong track record in regulated