Senior Preclinical Biostatistician H/F Astek

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.
Your mission (should you decide to accept it):

Reporting to our partner's ClinOps Biometrics department, and working with internal teams and service providers, you will be responsible for supervising statistical operations within the framework of clinical study projects sponsored by our partner (primary and secondary data).

Your daily activities will be:

Under the supervision of the Statistical Manager for a dedicated therapeutic area, you will be responsible for:

- Reviewing synopses and protocols (sample size, design, primary endpoint, methodology)
- Supervising statistical deliverables from providers (analysis plans, TFLs, interim analyses, etc.)
- Monitoring statistical study milestones
- Managing progress via provider dashboards
- Ensuring timely delivery of results and datasets, in accordance with quality standards (quality control / SAS programming)
- Reviewing clinical study reports and external communications
- Being responsible for completing the eTMF file
- Creating SAS statistical programs and validating the codes
- Monitoring and applying regulatory standards (FDA, EMA, ICH, etc.)

Your future team:

[Short description of the human environment of the mission - Example: "

- You will join a young, enthusiast, motivated and dynamic team with strong ambitions, and ready to welcome you.
- You'll be trained by a highly knowledgeable coach who will give you all his success secrets."]