Senior Biostatistician
Sunnyvale, CA, United States
USD 115K-205K (estimate) Senior-level Full Time
Tasks
- Apply adaptive designs and Bayesian methods
- Collaborate with data management on edit specifications
- Create mock tables listings and figures
- Develop SOPs and WIs for statistical analysis plans
- Develop study power analyses and sample size justifications
- Draft methods results and analysis interpretation for regulatory submissions
- Ensure 21 CFR Part 812 compliance
- Ensure ISO 14155 compliance
- Ensure good clinical practice compliance
- Improve quality control for statistical workflows
- Interpret statistical results for cross functional teams
- Lead statistical sections for clinical protocols
- Manage clinical study portfolio
- Perform clinical trial data analysis
- Provide mentorship to junior biostatisticians
- Search scientific literature for evidence generation
- Set biostatistics project roadmaps and priorities
- Standardize statistical analysis pipelines
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 812 | Adaptive Design | Analysis Plans | Bayesian Methods | Biostatistics | Clinical Practice | Clinical Trial Design | Clinical trial | Data Management | Good Clinical Practice | ISO 14155 | Power analysis | Protocol development | Python | Quality Control | R | Regulatory Submissions | SAS | SOP Development | Sample Size | Sample Size Calculation | Scientific publication | Statistical Analysis | Statistical analysis plans | Statistical programming | Tables Listings and Figures | Trial design
Education
Regions
Countries
States
Cities
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