Biostatistician – Waterloo, Belgium (F/M)

Alsinova; Waterloo; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Experience accelerator

Diverse projects for clients

Tailored career path

Continuous learning

Inclusive work environment

Résumé du poste

Alsinova is seeking an experienced Clinical Statistician to lead studies from design through execution within a CRO framework. The role emphasizes statistical strategy, protocol input, and robust analysis planning in collaboration with project teams.

Ideal candidates have 3–5 years Biostatistics experience, strong SAS skills, and familiarity with ICH/EMA/FDA guidelines; CDISC ADAM is a plus, and excellent English is required.

Qualifications

• 3–5 years experience in Biostatistics in pharmaceutical/CRO environments.
• Strong knowledge of international guidelines (ICH, EMA, FDA).
• Knowledge of CDISC ADAM is a plus.
• Good level of English.

Responsabilités

• Manage a study from design to execution, across various designs.
• Establish study strategy using statistical methods (power modelling, scenarios).
• Monitor and implement mitigation plans to minimize statistical risk.
• Provide input to protocol design, endpoints, randomization, and sample size.
• Develop SAP and coordinate reviews; review TFLs with statisticians; QC analysis methods.
• Validate study datasets and analysis programming specs; approve deviations from TFL formats.
• Propose conclusions for Statistical Analysis Results and respond to stat questions.

Connaissances

Interpersonal skills

Global study process view

English proficiency

Outils

SAS software

Description du poste

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 scenario, set up power).
• Monitoring, set up mitigation plan to minimize risk of stat failure.
• Provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat 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 stat 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 stat question (e.g. inspection, regulatory question).

• You have 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.).

You:

• You have 3 to 5 years experience in the field of Biostatistics in a pharmaceutical/Contract Research Organization environment.

• You are familiar with SAS software.
• You have a strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, …).
• A good knowledge of CDISC standards (ADAM) is a plus.

• You have a good level of English.

• You have 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.).

Alsinova – An Astek Company

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 730 M€ in 2025.

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 #TopEmployer2026 certified HR practices

Let’s move forward.