Sr. Director, Biostatistics
Tasks
- Author statistical analysis documentation
- Conduct ad-hoc data analyses
- Create statistical models
- Develop and maintain biostatistics SOPs
- Develop statistical analysis plan
- Develop trial design and protocol
- Interpret clinical trial data
- Lead phase 3 study statistical strategy
- Oversee biostatistics team
- Oversee external vendors
- Perform statistical analysis
- Prepare regulatory deliverables
- Provide executive program updates
- Report results
- Support BLA submission activities
- Support FDA discussions
Perks/Benefits
- N/A
Skills/Tech-stack
Analysis planning | Biostatistics | Clinical Trial Data | Clinical Trial Data Interpretation | Clinical Trial Design | Clinical trial | Data Interpretation | FDA Submissions | Microsoft Excel | Microsoft PowerPoint | Microsoft Word | Predictive Modeling | Python | R | Randomized Trial | Randomized Trial Analysis | Regulatory Submissions | SAS | SOP Development | Statistical Analysis | Statistical Analysis Planning | Trial Analysis | Trial design | Vendor management
Education
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