The European Medicines Agency (EMA) evaluates and supervises medicines in the European Union to protect and promote public health. EMA relies on clinical study data submitted by medicines developers and is expanding its ability to receive and analyse individual patient level data in structured electronic formats. This supports regulatory assessments of pharmacokinetics and pharmacodynamics, modelling and simulation, efficacy and safety, and GCP compliance.

EMA is seeking Data Science Specialists to support these activities and contribute to the work of the Network Data Steering Group (NDSG), which drives the European medicines regulatory network strategy to optimise data use and leverage data and artificial intelligence.

Your tasks

In this job you will Work as a Data Science Specialist supporting the receipt, validation, characterisation, analysis and visualisation of clinical study data. Key activities include:

• Support the development of business processes for structured clinical study data received from medicines developers
• Create, validate, execute and generate code using data analysis tools to support regulatory questions
• Perform analyses of clinical study data to support marketing authorisation evaluations and prepare analysis reports
• Validate clinical study data submissions according to relevant standards
• Ensure data quality and robustness in line with the Agency’s data governance framework
• Support training and knowledge sharing on data analysis tools across the EU regulatory network
• Contribute to guidance on data submission, validation, characterisation, analysis and visualisation
• Provide data management and analytics input to IT solutions supporting clinical data processing workflows
• Communicate scientific and data aspects of the work with internal and external stakeholders and support presentations and publications
• Support the planning, organisation and summarising of scientific meetings and workshops
• Work in a multicultural environment with multidisciplinary teams

Your profile

Apply if you meet these eligibility criteria:

General conditions

• Full rights as a citizen of an EU Member State, Iceland, Liechtenstein or Norway
• English at level C1 and another EU language at level B2
• Military service obligations fulfilled where applicable Specific conditions
• University degree of at least three years in Data Science, Informatics, Computer Science, Engineering, Statistics, Mathematics, Biology, Medicine, Pharmacy or related fields requiring advanced analytical skills
• At least three years of relevant professional experience after obtaining the qualifying degree

General and specific conditions must be evidenced through the application and at interview.

Only eligible candidates will be assessed.

Competency areas

• Competency in data management including data validation
• Competency in data analytics including cleansing, integrating and analysing clinical study data Proven experience
• Using statistical software (R and SAS) and data visualisation tools (R Shiny, Power BI)
• Preparing reports with narratives, tables, listings and figures
• Working with structured datasets such as CDISC SDTM and ADaM
• Basic biostatistics understanding Competencies you need to have Sub family
• Data management (Advanced)
• Data analytics (Intermediate)
• Applied knowledge (Intermediate) Grade
• Adaptability and agility (Intermediate)
• Analysing and problem solving (Intermediate)
• Prioritising and organising (Intermediate)

Core

• Ethics and integrity (Intermediate)
• Team collaboration (Intermediate)
• Customer centricity (Intermediate)
• Results orientation (Intermediate)
• Communication (Intermediate)
• Cross cultural sensitivity (Intermediate)
• Continuous learning and self development (Intermediate)

What we offer

• Meaningful work contributing to safeguarding public health in Europe by supporting evidence based evaluation of medicines, working in a multinational and multidisciplinary environment
• Opportunities for professional growth including internal mobility, mentoring, technical and scientific training, and career development programmes
• A collaborative culture that values innovation in data, analytics and digital technologies

Benefits:

• Initial five year contract with a competitive monthly tax free salary and household and children’s allowances where applicable
• Privileges for expatriate staff including expatriation and education allowances and additional home leave where appropriate
• Relocation assistance for staff moving to the Netherlands
• Excellent health insurance and social benefits as well as a pension scheme