Hybrid-Eligible CMC Statistics Director

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

Job summary

Vertex Pharmaceuticals Inc seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, including development, manufacturing, validation, and regulatory submissions. You will establish a Statistics Center of Excellence, drive DOE practices, and promote data-driven decision making across Development, MSAT, Quality, and Regulatory Affairs.

Ideal candidates hold a PhD or MS in a quantitative field with 10–12+ years in pharma/biotech and experience

Qualifications

• Ph.D. in Statistics or related field with 10+ years of industry experience.
• MS in Statistics or related field with 12+ years of experience in industry.
• Experience supporting CMC development and regulatory submissions.
• Experience across biologics, cell/gene therapy, or small molecules.
• Proven success building statistical governance and best practices.
• Experience with AI/ML and digital manufacturing preferred.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Establish and lead the CMC Statistics Center of Excellence.
• Support DOE, PPQ, CPV, SPC, and process validation activities.
• Defend statistical content for regulatory submissions.
• Develop statistical training to improve data-driven decision making.
• Stay updated on industry trends in CMC statistics.

Skills

Statistical leadership

DOE

Multivariate analysis

Regression modeling

SPC

PPQ/CPV

Data analytics

Regulatory writing

Leadership

Communication

Education

PhD in Statistics or related

MS in Statistics or related

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Pharmaceuticals Inc seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, including development, manufacturing, validation, and regulatory submissions. You will establish a Statistics Center of Excellence, drive DOE practices, and promote data-driven decision making across Development, MSAT, Quality, and Regulatory Affairs.

Ideal candidates hold a PhD or MS in a quantitative field with 10–12+ years in pharma/biotech and experience