Associate Director, CMC Statistics
Core
Provide hands-on statistical leadership for Chemistry, Manufacturing, and Controls (CMC) activities in biologic drug development, including specification setting, stability trending, and lifecycle management.
Role type
Senior IC CMC statistics lead
Builds
Regulatory-defensible statistical strategies for drug substance and drug product development
Domain
Biopharmaceuticals / Oncology / CMC
Required skills
Specification setting, stability trending, shelf-life assessment, analytical method bridging, comparability assessments, process validation, risk-based sampling, statistical analysis planning, regulatory submission support, cross-functional partnership, statistical tool development
Preferred skills
None stated
Technologies
JMP, SAS, R, Python, Minitab
Responsibilities
Develop statistical strategies for specification setting and stability trending; Lead statistical evaluation of stability data and shelf-life modeling; Design and analyze analytical method bridging and validation studies; Lead statistical planning for comparability assessments; Provide statistical support for process characterization and product quality reviews; Apply advanced statistical methods to CMC datasets; Support investigations and change controls; Author statistical analysis plans and regulatory submission sections; Partner with external CDMOs and CROs; Develop statistical tools and governance approaches
Seniority
Senior, hands-on IC