Biostatistics Manager
Tasks
- Conduct Japan specific analyses for regulatory filings
- Conduct Phase 4 and post marketing surveillance statistical work
- Develop statistical analysis plans
- Evaluate MRCT Japanese participant rationale
- Lead clinical trials in Japan as Study Lead Statistician
- Plan and execute statistical strategies
- Prepare CTD statistical documents
- Provide statistical expertise for Japan regulatory submissions
- Review TFL shells and analysis outputs
- Review protocols and TFL specifications
- Support PMDA consultation responses
- Support clinical trial statistical review and input
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Adaptive Designs | Bayesian Methods | Biostatistics | CDISC | CTD | Clinical Trial Design | Clinical Trial Methodology | Clinical trial | Data Science | Epidemiology | Estimands | MRCT | PMDA | Python | R | Regulatory Submissions | SAS | SDTM | Statistical Analysis | Statistics | Trial design | Trial methodology
Education
Roles
Biostatistician | Biostatistics | Biostatistics Manager | Manager
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