CMC Statistics Assoc Dir
Core
Design, develop, and promote best practices, processes, and tools for CMC statistics to support product manufacturing and testing throughout the product life cycle.
Role type
Associate Director, CMC Statistics (Global CMC Statistics team)
Builds
Statistical tools, study designs, acceptance sampling plans, and criteria for physical test method development, qualification, and transfer.
Domain
Biopharmaceutical manufacturing (CMC) and Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Applied Statistics, Industrial Statistics, Non-clinical Biostatistics, Statistical Process Control, Process Capability Analysis, Design of Experiments, Acceptance Sampling Plans, Regression Analysis, Hypothesis Testing, Simulation, SAS Programming, JMP, Project Management
Preferred skills
Biopharma manufacturing operations expertise, Advanced degree in Applied/Industrial Statistics, Statistical thinking leadership
Technologies
SAS, JMP, Artificial Intelligence (AI) tools
Responsibilities
Drive improvements and standardization in statistical analysis areas; Use AI tools to enhance business processes; Review and provide quality oversight of technical documents; Support development and review of SOPs; Guide development and maintenance of statistical tools; Lead cross-functional teams in statistical thinking; Develop innovative strategies and technologies; Stay current on scientific and industry trends; Participate in external conferences.
Seniority
Senior, hands-on IC with leadership responsibilities