Website Alsinova
What we will accomplish together:
Alsinova, a subsidiary of the Astek Group, is a consulting firm specialized in Life Sciences. We support our pharmaceutical, biotech, and medtech partners by providing high-level expertise in clinical development, regulatory affairs, data, quality, and biomedical sciences.
Your mission (should you decide to accept it):
As part of a strategic collaboration with a major player in the healthcare industry, we are looking for an experienced Clinical Biostatistician to contribute to oncology clinical trials (Phase I and III).
Your daily activities will be:
Phase III Study:
- Statistical support for ongoing study follow-up (data review, data surveillance, pre-lock meetings)
- Implementation and monitoring of the data surveillance plan, including event prediction curves
- Development, review, and implementation of table shells for the Clinical Study Report (CSR)
- Preparation and validation of programs to generate outputs defined in the SAP and for exploratory analyses
- Contribution to the writing and review of the CSR
Phase I Study:
- Finalization and follow-up of the Biomarker and PK/PD statistical analysis plans and related TLGs
- Review of ADS/tables, oversight and validation of statistical programming
- Full study ownership on a separate Phase I trial:
- Shell table drafting, data surveillance preparation
- Output validation, deviation analysis, and additional analyses in response to Health Authority requests
You:
- Advanced degree in Biostatistics, Applied Statistics, or related field.
- Solid experience in pharmaceutical or biotech environments
- Proven track record in oncology trials, particularly early (Phase I) and confirmatory (Phase III) phases
- Strong command of SAS and familiarity with clinical reporting and regulatory standards
- Professional proficiency in English is required
We base our relationships on:
- Respect for employees and clients, and their aspirations,
- Personalized support for employees and clients,
- Regular career management,
- Transparent communication,
- Constant responsiveness, availability, and attentiveness.
Alsinova
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.
Our benefits
Joining Astek means choosing:
- an experience accelerator, where every assignment is an opportunity to progress
- access to a multitude of technically exciting projects for our clients as well as internally
- individualized, local support for a tailored career path
- continuous learning, thanks to our internal training academy
- a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices
Let’s move forward.
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