Are you interested in the context of drug development and regulatory science and are you ready for a challenge? We are looking for you! You are going to focus on developing and validating the framework for regulatory assessment of advanced methods. The position is part of the Horizon Europe INVENTS project: “Innovative designs, extrapolation, simulation methods and evidence-tools for rare diseases addressing regulatory needs” kicked off on January 1st 2024. The project is funded under the Horizon Europe framework program and brings together 15 partners from 9 countries.

INVENTS will provide clinical trial stakeholders, trialists and medicine regulators with a generalizable framework encompassing methods, workflows and evidence-tools to improve the level of evidence for regulatory decision making in rare diseases. This will be achieved through the development and validation of improved extrapolation models, simulation and in silico trials, model based clinical trial design and evidence synthesis methods.

In this 5 year postdoc project you will focus on developing and validating the framework for regulatory assessment of these advanced methods. It will include approaches to assess robustness and maturity of the computational models involved, and set criteria for validation. To do so, extensive data sets are available from representative selected use cases provided by two major pharmaceutical companies, Novartis and Roche, as well as Real World Data from the French National Data Bank for Rare Diseases (BNDMR). You will closely collaborate with the scientists involved in developing the models, methods and clinical trial designs, and will engage in detail with method development to ensure solid evidence tools and frameworks can be developed.

Tasks and responsibilities
You are expected to work in the local as well as the international team, and take up a leading role for the scientific work to be done. Key tasks foreseen for the you in the INVENTS project are:

• Evaluate existing assessment criteria for complex models, evidence frameworks and standards and identify key gaps, leading to a draft set of criteria. Focus will be on (a) models that support clinical, health economic and patient focused endpoints used for decision making and (b) criteria relevant for the situation of smaller sample sizes and datasets.
• Evaluate regulatory and health economic needs for qualification and assessment of complex modelling used in clinical trial design for rare diseases to support regulatory approval and reimbursement decisions.
• Apply (draft) criteria and assessment approach to the (new) methods and case studies from Novartis and Roche.
• Create and validate the overarching framework and associated evidence tools.

We offer an exciting Postdoc position for a scientist with a strong background in (medical) statistics, preferably in the context of drug development and with a keen interest in methodology of clinical research, drug development and regulatory science. Expertise or interest in building decision frameworks is an advantage.

Our ideal candidate has a PhD-degree in (bio) statistics, mathematics, decision theory or a related field. Preferably you have a solid background in experience in mathematics and proven experience in methodological research related to drug development or regulatory science during and after your PhD. You are someone with a proven scientific interest in medical applications, for example through publications and collaborative projects. You also have well-developed social skills directed to work in multidisciplinary and international teams.

Fixed-term contract: 5 years.

At Radboud university medical center, you build on your future. We are committed to providing the best care, education, and research. And we are true to our word, because we help you develop and seize opportunities and give you the room to grow. As an employer, we believe that employees should feel vital and happy at work in all stages of life. We are also committed to creating a healthy and safe working environment. Our employment conditions contribute to that. What we offer:

• Salary depends on knowledge and experience. A gross monthly salary in scale 10/11 between € 3.359 and € 6.156 (for a full-time appointment). You will also receive an 8% holiday allowance, an 8.3% end-of-year bonus, and a 47% to 72% bonus for working unsocial hours.
• Plenty of opportunities for personal development. You can take a variety of courses in our online learning environment. You can also share knowledge with colleagues through digital learning spaces – perfect for getting inspired and inspiring others.
• Your well-being and vitality are our priorities. For instance, you can enjoy a 40% discount on a sports subscription at the Radboud Sports Center along with access to the Healthy Professionals program designed to assist you in managing your energy. If you are going through a life-changing event, our Company Support Team and a personal coach are there to help you.
• If you are going through a life-changing event, our Company Support Team and a personal coach are there to help you.
• Support in achieving a good work-life balance at every stage of your life. This includes advice and training courses (from ‘Millennial Dilemmas’ to ‘Your Career After 57’), activities at our own mindfulness center, and informal caregiving consultations if you have questions about juggling work and caregiving responsibilities at home.
• 168 holiday hours per year (23 days) based on a 36-hour working week.
• 26 weeks of parental leave, nine of which are paid.
• A good collective pension scheme with a 70% reimbursement of your pension premium.
• Discounts on health insurance and ten other types of insurance, from home insurance to legal assistance.
• An allowance for your travel expenses or a working-from-home allowance of €2 per day.

Radboudumc

The Research and Education group Biostatistics is part of the Science Department IQ Health at Radboudumc. It has a strong track record in statistical methodology for clinical research, with a focus on innovative designs and analysis of clinical research for personalized medicine and rare disorders, prediction modeling and modeling for infectious diseases. It has extensive joint projects with medical and research departments within the Radboudumc, and is engaged in multiple national and international research projects in its key research areas. The section has a longstanding collaboration with the Dutch Medicines Evaluation Board (MEB-CBG), thus acting at the forefront of drug development and regulatory science.

Radboudumc
Welcome to Radboud university medical center (Radboudumc), where our research groups strive for innovative solutions that make impact on health and healthcare. We challenge the status quo to overcome current and future health challenges. Our goal is to shape the future of healthcare for generations to come. Our focus is on prevention, sustainability, and meaningful care, which we achieve through our in-depth understanding of disease mechanisms, clinical science, public health research, medical technology and data science. Our approach is centered on breakthroughs that can truly enhance personalized healthcare and public health.

At Radboudumc, a comprehensive range of research programs provide the compass for our research efforts. Each program has a clear goal, where collaboration within and outside our organization is highly valued. We integrate care, education and research in partnership with our patients to ensure that our research programs have significant impact on health and healthcare. We invite you to join us in our mission to create a healthy future for all.