Principal Biostatistician
Tasks
- Create graphical representations of clinical trials data
- Develop maintain and train SOPs
- Develop statistical analysis plans
- Lead ISS ISE submissions
- Lead biostatistics on clinical studies
- Maintain statistical integrity of clinical trials
- Manage biostatistics timelines and budgets
- Mentor and coach junior biostatisticians
- Perform analyses from statistical analysis plan
- Perform exploratory analyses
- Perform post hoc analyses
- Perform statistical quality control
- Prepare and review clinical study report sections
- Program data listings
- Program statistical summary tables
- Provide senior level peer review
- Provide statistical support to external clients
- Review case report forms for consistency
- Support regulatory meetings with statistical expertise
- Write statistical sections of clinical protocols
Perks/Benefits
- Career advancement
- Flexible work schedule
- Generous time off
- Hybrid work environment
- Positive work/life balance
Skills/Tech-stack
Budget Forecasting | Clinical Trial Design | Clinical study reports | Clinical trial | Clinical trial analysis | Data Integrity | Data Listings | Data Management | FDA | GCP | ICH GCP | ISE Submissions | ISS Submissions | Project Management | Protocol writing | Quality Control | Regulatory Compliance | SAS | SAS programming | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Summary Tables | Trial design
Education
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