Director, CMC Statistics & Data Analytics

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

Benefits offered by this job

Hybrid-Eligible or On-Site Eligible

Annual bonus and equity awards

Comprehensive benefits: medical/dental

Job summary

Vertex Pharmaceuticals Incorporated seeks a CMC Statistics Director (Scientific Fellow) to lead statistical science across the product lifecycle, from development to regulatory submissions. You will establish the CMC Statistics Center of Excellence, drive DOE, CPV, and process analytics, and partner with Development, MSAT, Quality, Regulatory, and Data & Digital teams to enable data-driven decisions.

The role emphasizes scientific excellence, collaboration, and continuous improvement, with

Qualifications

• Ph.D. or MS with extensive industry experience in CMC statistics and pharmaceutical manufacturing.
• 10+ years (PhD) or 12+ years (MS) of relevant experience in regulated environments.
• Proven ability to establish governance, best practices, and analytics capability.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Lead the CMC Statistics Center of Excellence and establish standards.
• Support DOE, CPV, PPQ, CPV, SPC, and lifecycle management programs.
• Defend statistical content for regulatory submissions and health authority interactions.
• Develop statistical training programs to raise organizational statistical literacy.

Skills

Statistical methodologies

DOE (Design of Experiments)

Multivariate analysis

Regression modeling

Process capability analysis

Statistical process control

Regulatory submissions

Data integrity (ALCOA+)

Leadership / stakeholder management

Communication & training

Education

Ph.D. in Statistics/Biostatistics/Data Science

M.S. in Statistics/Industrial Engineering/Data Science

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Pharmaceuticals Incorporated seeks a CMC Statistics Director (Scientific Fellow) to lead statistical science across the product lifecycle, from development to regulatory submissions. You will establish the CMC Statistics Center of Excellence, drive DOE, CPV, and process analytics, and partner with Development, MSAT, Quality, Regulatory, and Data & Digital teams to enable data-driven decisions.

The role emphasizes scientific excellence, collaboration, and continuous improvement, with