Trainee (Analysing clinical trials data: From application to results)

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 Methodology Office within the Data Analytics and Methods Task Force.

Specific objectives and projects

During your traineeship, you will contribute to two data analytics projects. The planned time per project is indicative with some possibility to amend based on the profile and interest of the selected trainee.

1) Analysing data about clinical trials (60% full time equivalent)
The Clinical Trials Information System (CTIS) is the European Union’s central clinical trial register. It holds a wealth of information about clinical trial applications by sponsors and regulators' assessments of these applications. However, these data are currently not analysed in its full potential. EMA will pilot the analysis of CTIS data with the objective to generate operational and scientific insights to optimise the regulatory assessment process and inform regulatory decisions. 

The trainee will contribute to the following activities in collaboration with other team members:
- Participate in cross-disciplinary discussions to translate operational and scientific questions on clinical trials into fit-for-purpose analyses;
- Visualise and analyse data from clinical trials, from simple descriptive analyses to advanced analytics including artificial intelligence methods;
- Report and present the analysis results.

2) Analysing individual patient data from clinical trials (40% full time equivalent)
EMA is coordinating an ongoing project on analysing individual patient data from clinical trials in support of regulatory decision-making by EMA’s Committee for Medicinal Products for Human Use (CHMP). The main objective is to clarify the benefits of analysing data in support of the CHMP as well as the operational, resource and technological needs.

Building on lessons learnt from the project interim report in early 2024, the trainee will contribute to the following activities:
- Explore the validation of compliance of submitted data files against Clinical Data Interchange Standards Consortium (CDISC) data standards, using suitable validation software; 
- Share knowledge on analysing data from clinical trials, e.g. create and deliver a presentation on the validation against CDISC data standards. 

Learning outcomes

In this traineeship, your learning objectives will improve your skills/knowledge and gain experience in the following areas: 

1)    Analysing and visualising data from and about clinical trials
2)    Running analyses in a state-of-the art platform for analytics and artificial intelligence
3)    Data standards for clinical trials
4)    Summarising complex information and presenting it clearly to experts and laypersons
5)    Working in an interdisciplinary project team, contributing to its objectives through individual tasks and collaboration
6)    The assessment of clinical trial applications and the scientific evaluation of marketing authorisation applications
7)    The European Medicines Regulatory Network and its stakeholders, including other international regulatory agencies (e.g. US FDA, Japan PMDA)
8)    Working in a stimulating and international 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 related field, or other life sciences preferably with a curriculum component on clinical trials  (minimum of three years or more) that must have been obtained within the last 12 months (graduated between 20 May 2023 and 20 May 2024) 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

In addition to the eligibility criteria, you will have a strong interest in data analytics.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2024 – 31 July 2025) 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 €1,858.31 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.