Senior Associate Director, CMC Statistics (Biologics)

Summit Therapeutics; Princeton (NJ); Presencial; USD 180.000 - 200.000; Jornada completa

Descripción de la vacante

Summit Therapeutics Inc. in Princeton, New Jersey seeks an Associate Director, CMC Statistics to lead statistics across Chemistry, Manufacturing, and Controls.

You will partner with Analytical Sciences, MSAT, Manufacturing, Quality, and Regulatory, driving regulatory-defensible statistical strategies for drug substance and product development. The role involves planning analyses for specification setting, stability, comparability, and method validation, with global regulatory submissions and

Formación

• Advanced degree in Statistics, Biostatistics, or a related quantitative discipline.
• Minimum of 10 years of industry experience applying statistics to biologics CMC activities.
• Strong knowledge of regression, ANOVA, mixed models, and multivariate analysis.
• Experience with regulatory data and health authority interactions.
• Proficiency with JMP, SAS, R, Python, or Minitab for reproducible analyses.

Responsabilidades

• Serve as the CMC statistics SME for biologic drug substance and product development.
• Develop statistical strategies for specification setting and acceptance criteria.
• Lead stability trend analyses, shelf-life modeling, and comparability assessments.
• Design and analyze analytical method transfer, qualification, and validation studies.
• Prepare and review regulatory submission content and health authority responses.

Conocimientos

Communication

Leadership

Independent work

Educación

PhD in Statistics or related field

MS in Statistics (optional)

Herramientas

JMP

SAS

R

Python

Minitab

Descripción del empleo

Summit Therapeutics Inc. in Princeton, New Jersey seeks an Associate Director, CMC Statistics to lead statistics across Chemistry, Manufacturing, and Controls.

You will partner with Analytical Sciences, MSAT, Manufacturing, Quality, and Regulatory, driving regulatory-defensible statistical strategies for drug substance and product development. The role involves planning analyses for specification setting, stability, comparability, and method validation, with global regulatory submissions and