Specialist CMC Statistician
Core
Design, develop, and promote statistical best practices and tools to support product manufacturing, testing, and qualification throughout the product life cycle in biologics and monoclonal antibody processes.
Role type
Specialist CMC Statistician (Biopharma Manufacturing)
Builds
Statistical analysis, study designs, acceptance sampling plans, and criteria for physical test methods and delivery devices.
Domain
Biopharma / Biologics Manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, Simulation, SAS programming, R programming, JMP statistical software
Preferred skills
Advanced degree in Applied or Industrial Statistics, 3+ years applying statistical methodologies to Biopharma manufacturing, Proficiency in statistical tools for biologics and monoclonal antibodies processes
Technologies
SAS, R, JMP
Responsibilities
Develop experimental studies, perform statistical analysis, and document results in technical reports; Write standardized code (R/SAS) and report templates; Mentor technical associates on statistical techniques; Participate in continuous improvement efforts for biologics processes; Stay updated on biotechnology industry trends and guidance documents
Seniority
Specialist, hands-on IC
