Data Scientist - Statistician - CMC H/F - Astek

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):

As part of the Data Science and Innovation team, and in close collaboration with internal scientific experts, you'll work on high-impact assignments where data science meets CMC and regulatory challenges

Your daily activities will be:

Your work may include:

- Performing statistical analyses and machine learning modeling in a CMC context
- Establishing interpretation thresholds based on experimental data
- Supporting verification and validation phases of diagnostic products
- Ensuring compliance with regulatory standards (FDA, GMP, ISO)
- Collaborating with multidisciplinary teams and contributing to project documentation

Your future team:

Join a CRO where data science is a core pillar of innovation. You'll evolve in a collaborative and agile environment, with freedom to explore new approaches and tools, and with access to a wide variety of scientific datasets across pharma, dermo-cosmetics, and biotech.

You:

- Master's degree in Data Science or Applied Statistics

- Experience: 7+ years in applied data science/statistics, with proven experience in CMC-related projectsTechnical Skills:
Strong expertise in statistics and machine learning
- Hands-on experience with diagnostic data, especially immunoassays
- Solid understanding of CMC processes and regulatory expectations
- Familiarity with FDA, GMP, and ISO standards