Biostatistician / Statistician (Contractor

The job

As our (Bio)Statistician, you will be working very closely and directly with scientists and engineers on our core projects across our R&D portfolio.

You will be a critical contributor for the team and will lead statistical support and analysis for all of the quality and regulatory activities within the company.

This includes sampling strategies, investigation plans, product performance data analysis, clinical trials, stability trials and validations.

You will have a responsibility to ensure that results are interpreted correctly, and to advise project teams and decision makers on the conclusions that can be drawn.

You will need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended.

All the activities of the statistician follow the requirements of ISO 13485 and 21 CFR 820.

As a key member of the team you are a leader and a champion of design controls and data integrity.

Responsibilities**- Preparation of analysis plans and creation of detailed specifications for data analysis, consistency checks, tables, and figures to present complex data in understandable formats;

• Communicates with team members regarding statistical analysis issues. Interpretation, analysis and creation of statistical sections of study reports;
• Familiar with a variety of the statistical concepts, practices, and procedures;
• Relies on extensive experience and judgment to plan and accomplish goals. Performs a wide variety of tasks;
• Direction of the work of others. Thinks creatively.
• You obtained a master's degree / Ph.

D in Mathematics / Statistics;

• You have considerable relevant experience in a similar area;
• Prior Quality experience in the IVD industry or the medical device industry is a clear asset;
• Clinical trial experience is desirable;
• You are familiar with Quality System standards / regulations (ISO 13485, 21 CFR 820);
• You are also familiar with a variety of the statistical concepts, practices, and procedures;
• You have a good working knowledge of statistics packages like "SAS", "R", "SPSS", "MINITAB" etc;
• You are able to clearly communicate and present statistical concepts, data and reports, even to nonstatisticians;
• You are able to represent the team in crossfunctional interactions with regulators, subcontractors, and/or vendors;
• You are driven by the impact you have on science;
• You work well in a team but equally you can operate autonomously with personal accountability for objectives;
• You have an analytical, creative mindset with a cando attitude, intellectual curiosity, eager for continuous learning and passionate about your work and our mission;
• You have strong problemsolving skills. Solutions must be thorough, practical, and consistent with organization objectives;
• You have the ability to create technical reports, business correspondence, technical procedures, as well as, administrative procedures;
• Ethical and high integrity toward data and mathematical conclusions;
• You are fluent in English. Knowledge of Dutch is an asset;
• You feel comfortable in a startup environment and you can easily switch from one task to another;
• You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
• Our offices are located in Leuven. You will need to come on a regular basis to our offices but you will also be able to work remotely (hybrid way of working).

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