Senior Preclinical Biostatistician H/F - 75

Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10 000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.More on the Group on our websites https://alsinova.com and https://astek.net.Astek is committed to the employment of people with disabilities.

Joining Astek means choosing:an experience accelerator, where every assignment is an opportunity to progressaccess to a multitude of technically exciting projects for our clients as well as internallyindividualized, local support for a tailored career pathcontinuous learning, thanks to our internal training academya friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practicesLet's move forward.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."]