Principal Biostatistician FSP - Vaccines
Tasks
- Analyze clinical trial data
- Author and review SAP and TLF shells
- Contribute to regulatory submission dossiers
- Create analysis dataset specifications
- Create statistical analysis plans
- Develop clinical development plans
- Develop data management plans
- Ensure regulatory compliance
- Lead electronic submissions
- Program and validate SDTM and ADaM datasets
- Provide statistical leadership
- Review ADaM specifications
- Review SDTM specifications
- Review case report forms
- Review study protocols
- Review study reports
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | CDISC | Case Report Form | Data Management | Data Management Plan | Electronic submissions | R | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | TLF
Education
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