Principal Biostatistician FSP
Tasks
- Collaborate with sponsor cross-functional teams
- Contribute to concept sheets
- Coordinate statistical aspects across clinical trials
- Create statistical analysis plans
- Develop clinical development plans
- Develop study protocols
- Draft clinical sections for regulatory submissions
- Lead electronic submission of clinical data
- Manage biostatisticians and statistical programmers
- Participate in meetings with regulatory authorities
- Perform statistical analyses
- Provide statistical leadership
- Review analysis dataset specifications
- Review study reports
- Support development of sourcing strategy
Perks/Benefits
Skills/Tech-stack
Analysis Plan | Biostatistics | Case Report Form | Clinical Development | Clinical Development Plans | Clinical trials | Concept Sheets | Data Management | Development plans | Efficacy tables | Electronic submissions | QC | R | Regulatory Submissions | SAS | Safety tables | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | TLF
Education
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