Trainee (Analysing Clinical Trials Data: From
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**Selection procedure reference**: EMA/TR/10444
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
- 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 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- 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**:
- enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
- 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.
- 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- 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- 20 May 2024 23:59 CET**Assessments (remote)**
- From beginning of June 2024 to beginning of July 2024**Decision and offers**
- By end of July 2024**Placement start**
- 1 October 2024- 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
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