CMC Statistics Director — Lead Data-Driven Biotech Quality

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

Job summary

Vertex Pharmaceuticals seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, partnering with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive data-driven decisions and improve product quality and process robustness.

This role establishes the CMC Statistics Center of Excellence, defines standards, governance, and best practices, and leads advanced analytics, DOE, and process monitoring to support Vertex's

Qualifications

• Ph.D. or MS with extensive industry experience in CMC statistics.
• Experience supporting CMC development and regulatory submissions.
• Experience with biologics, cell/gene therapy preferred.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Lead the CMC Statistics Center of Excellence with governance and standards.
• Support DOE, CPV, PPQ, SPC, and process capability monitoring.
• Develop training programs to improve statistical literacy.

Skills

Statistical leadership

DOE design of experiments

Multivariate analysis

Regression modeling

CPV/PPQ/SPC

Regulatory submissions

SAS/R/Python

FDA/EMA knowledge

Data integrity ALCOA+

Leadership / stakeholder mgmt

Communication skills

Education

Ph.D. in Statistics or related field

MS in Statistics or related field

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Pharmaceuticals seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, partnering with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive data-driven decisions and improve product quality and process robustness.

This role establishes the CMC Statistics Center of Excellence, defines standards, governance, and best practices, and leads advanced analytics, DOE, and process monitoring to support Vertex's