During your traineeship, you will contribute to the development of training modules on relevant guidelines for “Training Curriculum: Biostatistics & Clinical Trial Methodology for regulators” and identification of gaps in training needs in EU network for Big Data topics that meet immediate regulatory needs.
You will familiarise yourself with the methodological aspects of major importance to the regulatory setting as outlined in the relevant ICH and Biostatistics Working Party guidelines. You should read and summarise each guideline, find relevant examples in relation to tasks performed by TDA-MET staff (e.g. contributions to Marketing Authorisation Applications, Scientific Advice and discussion meetings with stakeholders) and prepare a presentation that shall be used to train assessors in the EU network.
You will also contribute to the development of new and engaging training formats by researching suitable approaches and piloting them.
As outlined in the recommendations of the HMA-EMA Joint Big Data Taskforce, the identification of training needs and skills gaps within the EU network is necessary. You should hence outline plans on how to conduct relevant need analysed using available and suitable tools, followed by conducting, analysing and reporting such outcomes which will inform priority setting.
To be eligible for consideration for this placement, you are required to:
For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.
In addition to the eligibility criteria, you will have:
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