Principal Biostatistician/Senior Principal Biostatistician
Tasks
- Attend bid defense meetings for complex programs
- Author statistical analysis plans
- Consult on clinical trial study design
- Consult on regulatory strategy
- Create sample size calculations
- Develop and review procedural documents
- Develop statistical methods for clinical protocols
- Generate randomization schedules
- Lead NDA BLA MAA submissions statistical oversight
- Mentor and train biostatisticians
- Present statistical results
- Provide statistical leadership for clinical development
- Provide unblinded reporting to data monitoring committees
- Review statistical analysis plans
- Review statistical outputs for accuracy
- Review statistical sections of clinical study reports
- Serve as subject matter expert for study design areas
Perks/Benefits
- Disability benefits
- Discretionary annual bonus
- Health insurance
- Life insurance
- Paid time off for sick leave
- Paid time off for vacation
- Parental leave
- Retirement savings benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Adaptive study design | Analysis Plans | Bayesian adaptive study design | CDISC | CFR Part 11 | Clinical Trial Design | Clinical trial | Data Monitoring | Data Monitoring Committees | FDA Guidelines | ICH Guidelines | Part 11 | Randomization Schedules | Regulatory Submissions | Repeated Measures | SAS | Sample Size | Sample Size Calculations | Statistical Analysis | Statistical Methods | Statistical analysis plans | Study design | Survival analysis | Trial design
Education
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