Trainee (Clinical trials methodology and analytics for regulatory decisions)

About the traineeship programme

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

We are looking for a trainee in the Data Analytics and Methods Task Force.

Specific objectives and projects

The selected trainee will be working on two different projects:

• The main project is to analyse orphan designation applications including claims for significant benefit with a focus on indirect comparison methods. Specifically, the selected trainee will be involved in extracting and summarising study designs and analysis approaches (i.e. statistical methods and Effective Sample Sizes) that need to be extracted and summarized. The review should also take into account the related regulatory decisions. The project will inform the development of a Q&A on indirect comparisons as per 2025 workplan of the Committee for Orphan Medicinal Products (COMP) and support good reporting practices. The project should result in manuscript to be published in a peer-reviewed journal.  (expected time: approx. 80%)

• Finally, the trainee will support knowledge management activities for the Methodology Working Party (MWP) and Methodology European Specialised Expert Community (ESEC), e.g. by collecting, curating and sharing information of scientific outcomes (expected time: approx. 20%) 

Learning outcomes

The learning outcomes will be:

- Understanding of the European Medicines Regulatory Network
- Understanding of the Methodology Domain, i.e. the activities of the Methodology Working Party (MWP) and of the related European Specialised Scientific Expert (ESEC) Community
- Understanding of the work of the Committee for Orphan Medicinal Products
- Gain experience in carrying out analysis on methodologies used in clinical developments intended for regulatory decisions
- Improve skills in summarising complex information and presenting it clearly to experts and laypersons
- Gain skills to communicate effectively via written procedures
- Understanding various aspects of knowledge management and how to implement them in a complex scientific environment
- Develop networking skills in a multi-stakeholder and regulatory environment

Eligibility criteria

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 data science, statistics, biostatistics, applied mathematics, or a related field, preferably with a curriculum component on clinical trials, or life sciences degrees (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
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

• ability and willingness to gain an understanding of complex statistical methods
• interest in research
• preferably an understanding of clinical trial design
• organisational skills
• creative, analytical and logical mindset 
• communication skills for collaborating across a network

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills – cross-cultural sensitivity
• Working with others – team collaboration
• Adaptability – adaptability & agility
• Research and analytical skills – analysing and problem-solving

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.