Biostatistics Plan

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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
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