Associate Director, CMC Statistician
San Carlos, California, United States
USD 170K-198K Mid-level Full Time
Tasks
- Assess analytical method performance and lifecycle changes
- Author and review specification and justification of specifications documents
- Design and execute statistical analyses
- Develop specification and justification of specifications statistical strategies
- Provide statistical input to late stage development and PPQ
- Serve as CMC statistical lead for specification setting
- Support PPQ APR and CPV process consistency evaluation
- Support analytical method validation transfer bridging comparability
- Translate statistical concepts into regulatory ready recommendations for cross functional teams
Perks/Benefits
Skills/Tech-stack
ANOVA | Analytical method transfer | Analytical validation | Biostatistics | Comparability | Confidence Intervals | Control Charts | Cpk | Data Analysis | Design of Experiments | Equivalence Testing | JMP | Method Bridging | Method transfer | Minitab | Prediction Intervals | Process Capability | Process validation | Project Management | Python | R | Regression | Regulatory writing | SAS | Stability Modeling | Stability analysis | Statistical Reporting | Statistical modeling | Statistics | Technical writing | Tolerance Intervals
Education
Regions
Countries
States
Cities
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