Principal Biostatistician
Tasks
- Create and review statistical analysis plan
- Design clinical trial analysis plans
- Develop specifications for clinical outputs
- Ensure compliance with ICH and regulatory requirements
- Lead biostatistics activities for clinical studies
- Maintain project timelines and financial tracking
- Perform statistical analysis of clinical studies
- Provide mentoring and training to statisticians
- Provide statistical programming oversight
- Quality review of TLFs and datasets
- Represent biostatistics in meetings audits and bid defenses
- Review SDTM and ADaM specifications
- Review and oversee statistical output
- Review clinical protocols and synopses
- Support proposals and budget reviews
- Support trial design and consult teams
- Write clinical study reports interim and final
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Analysis Plan | Biostatistics | Clinical Protocol | Clinical Protocol Review | Clinical Trial Design | Clinical trial | ICH E6 | Logistic Regression | MS Office | Mixed Models | Mixed-effects | Mixed-effects models | Protocol review | Regulatory Compliance | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Survival analysis | TLF | Trial design
Education
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