PhD position ‘Use of external data in clinical trials'

Randomized clinical trials are widely accepted as the gold standard for assessing the safety and efficacy of new medical interventions. It is not always feasible to recruit the number of patients required for a fully powered clinical trial, and therefore, in some cases, the data of a clinical trial may be augmented by external data sources. Such external data may come from a previous clinical trial or from non-experimental studies and data sources. In recent years a variety of Bayesian statistical methods have been developed that enable this borrowing of information from external data, while providing safeguards against the effects of possible differences between data sources.
The project's primary objective is to enhance the understanding of methodological issues related to the use of external data in clinical trials. The project involves identifying practical and methodological barriers to implementation and conducting pertinent research to eliminate these obstacles. This encompasses refining theoretical aspects such as type I error and statistical power, exploring regulatory agencies' acceptability criteria, developing applicable software, and applying existing dynamic borrowing methods in practical research. The project is funded through a public-private partnership and performed in collaboration with the Danone Nutricia Research & Innovation (R&I) Center, located in Utrecht. You will work with datasets provided by Danone and focus on novel methodologies and applications that are directly driven by Danone’s research needs in the field of innovative nutritional science.

The outcomes of the PhD project will include publications in peer-reviewed statistical journals. Additionally, there is the possibility of creating statistical software tailored to the project's needs. You will also share your findings through internal and external presentations, including presentations at international conferences, and through engagements with stakeholders. Additionally, you will actively contribute to the institute's academic environment by participating in seminars, workshops, and collaborative research.

The maximum salary for this position (36 - 36 hours) is € 3.824,00 gross per month based on full-time employment.

In addition, we offer an annual benefit of 8.3%, holiday allowance, travel expenses and career opportunities. The terms of employment are in accordance with the Cao University Medical Centers (UMC).

Your daily worksite is the Department of Data Science & Biostatistics at Julius Center of UMC Utrecht. You will also be expected to work regularly at Danone Nutricia Research, conveniently located just across the street of the UMC Utrecht. The project will be supervised by Dr. Joost van Rosmalen (UMC Utrecht), Dr. Maarten van Smeden (UMC Utrecht) and Dr. Floor van Oudenhoven (Danone Nutricia Research).