Principal Biostatistician/Senior Principal Biostatistician
Tasks
- Attend bid defense meetings
- Author statistical analysis plans
- Calculate sample size
- Consult on clinical trial study design
- Consult on regulatory strategy
- Develop and review procedural documents
- Develop and review statistical methods
- Generate randomization schedules
- Lead NDA BLA MAA submission oversight
- Mentor and train statisticians
- Present statistical results
- Provide DMC statistical reporting
- Provide statistical leadership
- Review statistical analysis plans
- Review statistical output
- Review statistical sections of clinical study reports
Perks/Benefits
- Disability benefits
- Health insurance
- Life insurance
- Paid Time Off Sick Leave
- Paid time off (vacation
- Parental leave
- Retirement savings benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Adaptive Design | Analysis Plans | Bayesian adaptive design | CDISC | CFR Part 11 | Clinical Trial Design | Clinical trial | FDA Guidelines | ICH Guidelines | Part 11 | Randomization | Repeated Measures | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical analysis plans | Survival analysis | Trial design
Education
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