SNE/Epidemiology Specialist

About this position

The Data Analytics and Methods task force is looking for an epidemiology specialist to support the regulatory decision-making by identifying the right data sources and conducting the appropriate non-interventional (observational) studies with the best study and analytical methodologies to generate and deliver robust and reliable real-world evidence to the EMA, its committees, the regulatory network and other stakeholders, that will help optimise medicinal development and decision-making in Europe.

In this role you will

• Provide expertise for the identification, validation and utilisation of electronic healthcare data/claims data sources, patient registries and innovative data sources in Europe to support the EMA regulatory science strategy and the regulatory decision-making;
• Use and develop appropriate knowledge in the selection of fit-for-purpose real-world data to study populations, diseases and the performance of medicines (including vaccines) once placed on the market;
• Based on good (pharmaco-)epidemiology principles, design, conduct and coordinate non-interventional studies on the safety and effectiveness of medicinal products (with development of study protocol, statistical analyses and report writing) using in-house electronic health care databases or other pathways of RWE generation, including (but not limited to) drug utilisation studies, studies on the effectiveness of risk minimisation measures and etiological studies;
• Support EMA scientific committees and working parties in methodological aspects that contribute to scientifically sound and efficient drug development as well as informed decision-making process;
• Contribute to the development of scientific guidelines on the design and analysis of non-interventional studies;
• Develop training materials for the EU Regulatory Network on assigned subjects;
• Advise companies developing medicines on the design of non-interventional studies;
• Contribute to the yearly goal of the workstream as part of the team.

Apply if you meet these eligibility criteria

• Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway; 
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional / local public administration) in a European Union (EU) Member State and are due to remain in such employment for the foreseen duration of the SNE position.

Communication and professional contacts

Required to regularly communicate (verbally and in writing) information, which requires careful explanation and interpretation, taking into account what to communicate and how best to convey the information and messages. Writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature.

Regular professional contacts with others inside and/or outside the Agency on functional matters. Solicits/gives information, provides advice/guidance and creates use initiative. A likely requirement is to influence others’ thinking and negotiate with various parties within own job responsibilities. Normally connected to the Agency's core business or a project.

Essential requirements

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma;
• Minimum of a university degree in biomedical sciences, or public health, or regulatory science, or epidemiology/pharmacoepidemiology.

Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study.

Proven experience in at least one of the following:

• Designing and conducting non-interventional studies including operational work in protocol development and data analysis, interpretation and reporting;
• Designing or interpreting non-interventional studies, including e.g. innovative designs such as self-controlled designs and designs mixing clinical trial data with real-world data;
• Managing, transforming and analysing healthcare data, with practical use of statistical software like SAS, R or Python;
• Developing and delivering training on data analytics and methodology for observational data and studies;
• In working in a multidisciplinary team and in a multicultural environment.

Nice to have

Education

• Completed PhD or master’s degree in (pharmaco-)epidemiology or biostatistics applied to RWD, medicine, pharmacy, mathematics, data science, computer science or related scientific subjects.

Experience

• In working in a regulatory environment related to the evaluation of medicines or interacting with regulatory agencies;
• In coordinating research project;
• In using data analytics solutions which include artificial intelligence components and cloud technologies.