Staff GMP Statistician
Core
Lead strategic statistical deployment, root cause analysis, and process improvement to accelerate drug development and approval using advanced modeling in a GxP environment.
Role type
Staff/Principal GMP Statistician (IC with potential management)
Builds
Automation frameworks for statistical analyses and report generation within GxP environments
Domain
Biopharmaceutical manufacturing and quality assurance
Deliverable
production ML models | dashboards & analysis
Required skills
Bayesian and kinetic modeling, multivariate regression, design of experiments, difference and equivalency testing, control charts, predictive modeling, process simulation, forecasting, statistical software proficiency (JMP, Minitab, R, SAS), coding and automation
Preferred skills
Business analytics platforms (Power BI, Tableau), GxP automation framework experience
Responsibilities
Lead strategic deployment initiatives, apply advanced statistical modeling to historical data, build and validate automation frameworks, use predictive models for risk management, drive root cause analysis, translate statistical findings for executives, mentor colleagues
Seniority
Staff (9+ years) or Principal (7+ years), hands-on IC with potential management
