CMC Statistics Center of Excellence Director

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 193,000 - 290,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Generous PTO

Educational assistance

Student loan repayment

Commuting subsidy

401(k) matching

Equity awards

Job summary

Vertex Pharmaceuticals Inc. is seeking a CMC Statistics Director (Scientific Fellow) to lead statistical strategies across the product lifecycle, spanning development, manufacturing, quality, and regulatory submissions.

The role builds the CMC Statistics Center of Excellence, champions DOE, CPV, SPC, and data analytics, and partners with Development, MSAT, Regulatory Affairs, and Data & Digital teams to drive high-impact, data-driven decisions that improve product quality and manufacturing

Qualifications

• Ph.D. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or related quantitative discipline with 10+ years of relevant industry experience; or MS with 12+ years of relevant industry experience.
• Demonstrated experience supporting CMC development, process validation, manufacturing, quality operations, and regulatory submissions in a pharmaceutical/biotechnology environment.
• Experience applying statistical methodologies across biologics, cell and gene therapy, small molecules, and/or combination products preferred.
• Demonstrated success establishing statistical best practices, governance models, and capability-building programs within regulated environments.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead the CMC Statistics Center of Excellence and governance standards.
• Support DOE, process characterization, process optimization, and lifecycle management programs.
• Develop and implement PPQ, CPV, SPC, and process capability monitoring approaches.
• Support regulatory submissions with statistically sound content.

Skills

Statistical leadership

Design of Experiments (DOE)

Data analytics

Process monitoring

Regulatory submissions

Leadership

Cross-functional collaboration

Education

PhD in Statistics or related

MS in Statistics or related

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Pharmaceuticals Inc. is seeking a CMC Statistics Director (Scientific Fellow) to lead statistical strategies across the product lifecycle, spanning development, manufacturing, quality, and regulatory submissions.

The role builds the CMC Statistics Center of Excellence, champions DOE, CPV, SPC, and data analytics, and partners with Development, MSAT, Regulatory Affairs, and Data & Digital teams to drive high-impact, data-driven decisions that improve product quality and manufacturing