For one of our biotech partners in the region of Walloon Brabant we’re currently looking for a Non Clinical Statistician.
Working as part of a statistician team within the Statistician Unit (9 statisticians), you will work closely with people from New Product Introduction, Manufacturing, Quality Control, and Regulatory Affairs Departments to support the introduction of new vaccines and ensure consistent production and release of batches. You will provide statistical consultancy in relation with method or process transfer and validation, product homogeneity and stability, process optimization and control. You will be responsible for designing the experiments, analyzing the data, and writing reports and presentations for internal and external clients, including Regulatory Authorities.
You will continuously look for improvement in the way the team operates, i.e., the quality and efficiency of the service the team offers to its clients. You will also work in a GMP environment, where you will have to comply with standard operating procedures and authorities guidelines. In this project, you will have the opportunity to work on various business topics, applying a wide range of statistical methods. You will collaborate with all the actors of the supply chain using high quality standards.
- Provide internal statistical support in close interaction with other teams such as biologists, engineers and technicians
- Communication and sharing of results and conclusions with non-statisticians
- Identifying new opportunities to integrate statistical expertise into different vaccine development activities
- Seek and advice state-of-the-art and novel statistical approaches
- Ensure quality and scientific pertinence of proposed solutions, implementation, execution and outcomes
- Respect for the defined timelines
- University level in Sciences with a post-graduate in Biostatistics or equivalent experience, PhD is a plus
- 10 years of statistical experience in a research environment (pharmaceutical or biotechnology sector) or industrial environment
- Mastering the statistical theory (and its practical translation) of a broad spectrum of methodologies and experimental designs
- You should be familiar with statistical intervals (confidence, prediction, tolerance intervals), fixed and mixed effects ANOVA models, regression analysis, statistical process control, experimental designs and sampling plans (AQL)
- Proficiency with MS office and SAS (base, stat) is expected
- SAS, R, JMP computation practical knowledge
- Experience in pre-clinical or manufacturing statistics is an asset
- Fluency in French and English is desired
- A position with responsibility within a leading international company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation, including a range of fringe benefits