Biostatistician H/F Astek

Your mission (should you decide to accept it):

The Biostatistician we're looking for would be responsible for a whole study from design to execution for different study designs.

Your daily activities will be:

- Use statistical 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 Statistical Analysis Plan/Additional Analysis Request (involving sensitivity analysis to support robustness of result) and coordinate review.
- Review the Tables Figures and Listings (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 programming specification.
- Approve deviation from TFL format.
- Propose Statistical Analysis Results conclusion.
- Prepare answer to study specific stat question (e.g. inspection, regulatory question).