Les missions du poste
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).
Le profil recherché
You:
- You have 3 to 5 years experience in the field of Biostatistics in a pharmaceutical/Contract Research Organization environment.
- You are familiar with SAS and R software.
- You have a strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, ...).
- A good knowledge of CDISC standards (ADAM) is a plus.
- PK/PD experience is prefered.
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Publiée le 27/04/2026 - Réf : 7658