Principal Biostatistician/Senior Principal Biostatistician
Tasks
- Advise on regulatory strategy
- Attend bid defense meetings
- Author statistical analysis plans
- Consult on clinical trial study design
- Develop review procedural documents
- Develop sample size calculations
- Develop statistical methods for protocols
- Generate randomization schedules
- Lead NDA BLA MAA submissions
- Lead multi protocol clinical programs
- Mentor and train biostatisticians
- Provide statistical leadership
- Provide unblinded reporting to data monitoring committees
- Review statistical analyses for accuracy
- Review statistical analysis plans
- Review statistical sections of clinical study reports
- Serve as subject matter expert
- Write statistical methods sections
Perks/Benefits
- Disability benefits
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Retirement savings benefits
- Sick leave
- Vacation
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Adaptive Design | Analysis Plan | Bayesian adaptive design | Biostatistics | CDISC | CFR Part 11 | Clinical Trial Design | Clinical trial | Data Monitoring | Data Monitoring Committees | FDA Guidelines | ICH Guidelines | Part 11 | Randomization | Regulatory Submissions | Repeated Measures | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Survival analysis | Trial design
Education
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