Website Alsinova
What we will accomplish together:
Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.
Your mission (should you decide to accept it):
The Statistical Analyst & Programmer will be responsible of the provision of Services in support of Nonclinical or Clinical Statistical services.
Your daily activities will be:
- Participate in study preparation (eCRF, and DMP (iDRP and Domain datasets and individual listings) review),
- Participate in study SAS datasets structure (environmental tables) review,
- Develop the Tables, Figures and Listings (TFL) or Table Of Content (TOC) for clinical/Epi studies or assays
- Write technical specifications for elimination codes and protocol deviations
- Develop, maintain and document elimination codes and protocol deviations programs
- Write specifications for SAS/R/JMP programs/macros for analyses Datasets (project, study and/or standard),
- Develop, maintain and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis)
- Validate (peer review) and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis) and elimination codes and protocol deviations programs
- Periodic run and consolidation of elimination codes and protocol deviations
- Pre-Database Freeze cleaning checks on RAW data
- Creation of annexes of Stat report (SR tables, CTRS tables, XML files, …)
- Provide input on additional analysis request
- Perform Database Documentation for study specific analyses or at the standard level
- Review and ensure adherence to standards at the study or standard level,
- Support quality control (L1 QCs) and quality audit of deliverables,
- Develop, maintain and validate SAS programs for across-projects activities (PLDS, DSUR/PBRER, Web-Disclosure, eSubmission, iDAC)
- Develop, maintain and validate SAS standard macros for core standard activities
- Provide input into workload, technical and process initiatives
- Uses stat methodology to establish study strategy (eg. Power modeling of different scenario, set-up power monitoring, set-up mitigation plan to minimize risk of stat failure)
- Provides input to the concept protocol and protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
- Good communication and teaching skills.
You:
- Master in Statistics or related areas.
- Minimum 2 years of experience as statistical analyst / statistical programmer in product development within the pharmaceutical industry.
- Hands-on experience with SAS & R.
- CDISC knowledge: ADAM & TFL.
- Experience in multidisciplinary projects.
- Fluent English is required.
- French is a plus.
As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in
your personal and professional growth.
- Good communication and teaching skills.
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.
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.