- Consult with clients regarding clinical trial study design and regulatory strategy
- Develop and review statistical methods of clinical study protocols
- Provide and/or verify sample size calculations
- Author statistical analysis plans of complex study design
- Review statistical analysis plans written by other biostatisticians
- Review statistical output to ensure accuracy
- Review statistical sections of clinical study reports
- Generate and/or verify randomization schedules
- Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician