Senior Principal Biostatistician _Biopharma
Tasks
- Assess available data for business development
- Co author clinical study reports
- Critically review statistical interpretation
- Develop Integrated Analysis Plan
- Develop clinical trial study design
- Develop integrated safety and efficacy summaries
- Develop protocol and CRF
- Estimate sample size
- Lead Japan regulatory filings
- Oversee CRO for statistical deliverables
- Oversee patient randomization
- Perform quality oversight of statistical deliveries
- Perform statistical analyses
- Provide statistical expertise for compound development scenarios
- Provide statistical support for regulatory submissions
- Respond to regulatory agency requests
- Review statistical methods sections for clinical study reports
- Support Japan marketing authorization activities
- Support Japan specific programming tasks
- Support interactions with Japanese health authorities and KOLs
- Support manuscripts and manuscript review
- Support process improvement using lean
- Write Statistical Analysis Plans
Perks/Benefits
- N/A
Skills/Tech-stack
Biostatistics Quality Documents | CRO oversight | Clinical study | Clinical study report | Data reporting | Data reporting standards | GCP | ICH | Integrated Analysis | Lean | Patient randomization | Quality Documents | R | Regulatory Submissions | Reporting standards | SAS | Sample Size | Sample size estimation | Size estimation | Statistical Analysis | Study design
Education
Master of Science | Master of Science in Biostatistics | PhD
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