We are looking for a PhD candidate Biostatistics for our project to investigate and improve the use, uptake and advice on (statistical) model-based design and analysis of dose finding studies required for market approval of targeted therapies. Will you join our team?
Modern targeted anti-cancer medication, such as immunotherapy, has shown clear benefits for cancer patients and new products are continuously developed. Their mode of action is fundamentally different from classical therapies, which requires a different approach for early stage clinical trials that aim to determine a safe and effective dose range. The Medicines Evaluation Board aims to be at the forefront for such new approaches in its function to provide companies scientific advice on their development program, as well as assessing the results when submitted for regulatory approval. Against this exciting background, you investigate and improve the use, uptake and advice on (statistical) model-based design and analysis of dose finding studies required for market approval of targeted therapies. This involves amongst others scientific review of (public) regulatory assessment dossiers and performing statistical simulation studies to compare and improve different dose findings designs.
The project aligns with the Medicines Evaluation Board (agentschap College Beoordeling Geneesmiddelen) research themes "Personalised medicine & biomarkers and data-driven assessment" and Radboudumc research theme "Personalized health care" and the mission of the Department of Health Evidence to develop and apply methods for prediction and evaluation research. You will be part of scientifically strong teams, both at Radboudumc and the CBG, with a strong track record in drug development, regulatory science and statistics. This is also embedded internationally, with close collaboration across Europe thought the European Medicines Agency, allowing you a strong start for a career in drug development.
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