Biostatistics Plan
To develop methods to improve the quality and reliability of data:
- Sample design
- Sample size calculations
- Advise on randomization methods
- Writing or reviewing of statistical analysis plan
- Conduction of statistical analyses according to pre-defined analysis plans
- Provision advice and support for statistical analysis
- Provision of centralized statistical monitoring
- Management of Independent Data Monitoring Committee (IDMC) meetings
- Provision statistical reports for IDMC meetings
- Contribution to the reports to the funders, regulators and sponsors
- Conduction of additional exploratory analyses
- Medical writing - Contribute significantly to drafting of manuscripts, abstracts and presentations