Pubblicato su stage4eu il: 17/06/2020 European Medicines Agency, Trainee (Biostatistics and Clinical Trial Methodology)

EMA-European Medicines Agency
Domenico Scarlattilaan 6, Amsterdam, Paesi Bassi
Statistica/Data analysis
10 mesi. Inizio: 1 ottobre 2020 
1.360 euro mensili
Benefit: contributo alle spese di viaggio
L'offerta scade il 15/07/2020
Posti disponibili Non specificato
vai all'offerta
Attività:

 

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.

Requisiti principali:

 

To be eligible for consideration for this placement, you are required to:

  1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
  2. possess a university degree in statistics applied to medicine or life sciences with proved curricula in the design of clinical trials (minimum of three years or more) that must have been obtained within the last 12 months (July 2019 -July 2020) or be a university student on an Erasmus + or a similar programme or a PhD student.
  3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

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.

 
Additional skills

In addition to the eligibility criteria, you will have:

  • Excellent communication and organisational skills
  • Proven experience of writing structured documents and giving presentations
  • Proven experience of explaining technical subjects to non-technical people
  • If possible, some pharmaceutical and medical knowledge and/or understanding of the medicine regulatory system
  • If possible, understanding of the EU regulatory system

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