CMC Statistics Lead – Biologics (Princeton, Onsite)

Summit-Therapeutics; Princeton (NJ); On-site; USD 180,000 - 200,000; Full time

Job summary

Summit Therapeutics Inc. seeks an Associate Director, CMC Statistics to provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls.

You will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, and CDMOs/CROs to craft robust statistical strategies for drug substance and product development, ensuring regulatory-defensible decisions. The role requires translating complex data into clear conclusions for global submissions, commercial

Qualifications

• Advanced degree (PhD/ScD or equivalent) preferred; master’s degree considered.
• Minimum of 10 years of industry experience applying statistics to biologics CMC activities.
• Experience with regulatory data, quality systems, and cross-functional collaboration.

Responsibilities

• Serve as the CMC statistics SME for biologic drug substance and product development, registration, and lifecycle management.
• Develop and execute statistical strategies for release criteria, stability, and control limits.
• Lead statistical evaluation of stability data and transfer/validation studies; support regulatory submissions.
• Collaborate with Analytical Sciences, MSAT, Manufacturing, QA, Regulatory, Supply Chain, and external CDMOs/CROs.

Skills

Statistical leadership

Biopharmaceutical statistics

Cross-functional collaboration

Regulatory data analysis

Education

PhD in Statistics/Biostatistics

Advanced degree (PhD/ScD) preferred; master’s considered

Tools

SAS

R

Python

JMP

Minitab

Job description

Summit Therapeutics Inc. seeks an Associate Director, CMC Statistics to provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls.

You will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, and CDMOs/CROs to craft robust statistical strategies for drug substance and product development, ensuring regulatory-defensible decisions. The role requires translating complex data into clear conclusions for global submissions, commercial