What we will accomplish together: Alsinova is looking for an experienced Clinical Statistician looking for a place to grow.

Your mission (should you decide to accept it): The Biostatistician we’re looking for would be responsible for a whole study from design to execution for different study designs.

Your daily activities will be:

- Use statistical methodology to establish study strategy (e.g. power modelling of different scenarios, set up power).
- Monitoring, set up mitigation plan to minimize risk of statistical failure.
- Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, statistical analysis).
- Provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation).
- Develop Statistical Analysis Plan/Additional Analysis Request (involving sensitivity analysis to support robustness of result) and coordinate review.
- Review the Tables Figures and Listings (TFL), to coordinate review with the statistical analyst, to approve the TFL.
- Do the QC of the statistical analysis methodology.
- Validate study specific dataset & analysis programming specification.
- Approve deviation from TFL format.
- Propose Statistical Analysis Results conclusion.




- Prepare answer to study specific statistical question (e.g. inspection, regulatory question).

Qualifications

- 3 to 5 years experience in biostatistics in a pharmaceutical/Contract Research Organization environment.
- Familiar with SAS software.
- Robust knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).
- Good knowledge of CDISC standards (ADAM) is a plus.
- Good level of English.
- Good interpersonal skills and a good global vision of the study process, which allows you to ensure an efficient interface with the project teams (project leader, data managers, medical writers) and other external stakeholders (scientific experts, methodologists, etc.).

Benefits

- 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 certified HR practices. Astek is committed to the employment of people with disabilities.

📌 Biostatistician – Waterloo, Belgium (F/M) (Ottawa)
🏢 Alsinova
📍 Ottawa