To provide statistical expertise to support different clinical trial designs in a top bio-pharmaceutical company.
Responsible for a whole study from design to execution for different study designs:
- Use stat methodology to establish study strategy (e.g. power modelling of different scenario, set up power monitoring, set up mitigation plan to minimize risk of stat failure)
- Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
- Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)
- Develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
- Review the TFL, to coordinate review with the stat analyst, to approve the TFL
- Do the QC of the statistical analysis methodology
- Validate study specific dataset & analysis program specification
- Approve deviation from TFL format
- Propose SAR conclusion
- Prepare answer to study specific stat question (e.g. inspection, RA question)
- PhD, MS or Diploma in Statistics, Mathematics or Epidemiology or equivalent Area.
- Experience in SAS software and sample size computation for standard designs
- Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood