CMC Statistics Director — Hybrid Leader in Data & Quality

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

Benefits offered by this job

Total Rewards

Hybrid-Eligible

Education assistance

Paid time off

Job summary

Vertex Inc. seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle. This role partners with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to enable data-driven decisions and regulatory compliance.

The position establishes the CMC Statistics Center of Excellence, drives advanced analytics, and supports regulatory submissions with expert statistical content and training across the organization.

Qualifications

• Ph.D. with 10+ years in industry or MS with 12+ years in pharma/biotech.
• Experience supporting CMC development, process validation, regulatory submissions.
• Experience with biologics, cell/gene therapy, small molecules, or combination products preferred.

Responsibilities

• Provide strategic statistical leadership across the CMC lifecycle.
• Lead CMC Statistics Center of Excellence and governance.
• Support DOE, PPQ, CPV, SPC, and process monitoring across operations.

Skills

Statistical methods

DOE

Multivariate analysis

Regression modeling

CPV/PPQ

Statistical process control

Data integrity ALCOA+

Leadership & communication

Education

Ph.D. in Statistics or related field

M.S. in Statistics or related field with 12+ years

Tools

JMP

Minitab

SAS

R

Python

Job description

Vertex Inc. seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle. This role partners with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to enable data-driven decisions and regulatory compliance.

The position establishes the CMC Statistics Center of Excellence, drives advanced analytics, and supports regulatory submissions with expert statistical content and training across the organization.