SNE/Biostatistician Specialist (evidence generation)

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

About this position

In the context of regulatory submissions, provide statistical expertise to the design, conduct and analysis of clinical studies and the interpretation of study results. Additionally, contribute to international collaborations and strategic initiatives led by EMA in the area of biostatistics and clinical trial methodology.

In this job you will

• Support the Agency and its scientific committees (e.g. CHMP, COMP, PDCO) and working parties (e.g. MWP, SAWP) on methodological aspects that contribute to scientifically sound evidence generation and support efficient drug development.
• Contribute to the development and coordination of scientific guidelines on the design, conduct, analysis and interpretation of clinical studies.
• Advise companies developing medicines on the design, data collection, conduct, and analysis of clinical trials.
• Foster the development of training materials for the EU Regulatory Network on assigned methodological subjects.
• Liaise and engage with the academic community, research organisations and learned societies to foster the development, testing and utilisation of innovative methods for the design and analysis of clinical studies.
• Contribute to ongoing international collaborations, EMA projects and initiatives (e.g. EMA’s clinical study data project) as topic lead, coordinator or subject matter expert.

Apply if you meet these eligibility criteria

• Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine.
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the EU (at least level B2).
• Are currently employed in the public sector (such as a public intergovernmental organisation (IGO), national, regional or local public administration) in an EU Member State and are due to remain in such employment for the foreseen duration of the SNE position.

Managing resources

Work may include a degree of planning and coordination, including small projects, in alignment with given priorities.

Communication and professional contacts

The position requires regular communication of information (verbally and in writing), including careful explanation and interpretation, taking into account what to communicate and how best to convey the information; writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature; engaging professionally with others inside and/or outside the Agency on functional matters; soliciting/giving information, providing advice/guidance and using initiative to address tasks.

In particular, a Biostatistician Specialist will:

• Present on behalf of the Agency externally on biostatistical and methodological topics of importance to the Agency and Network.
• Represent the Agency and wider Network on external scientific groups.

Essential requirements

Education

A level of education which corresponds to completed university studies of at least three years attested by a diploma.

Field of study: Mathematics, statistics, epidemiology, pharmacy, medicine, or related scientific subjects.

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 clinical trials including operational work in protocol development, trial conduct and data analysis, interpretation and reporting.
• Managing, transforming and analysing clinical trial data, with practical use of statistical software like SAS, Python or R.
• Developing and delivering training on methodology for clinical trials.

Nice to have

Education

Completed PhD or master’s degree in mathematics, statistics or epidemiology.

Experience

Experience in the following areas would be desirable:

• Working in a regulatory environment related to the authorisation of trial conduct, the authorisation of medicinal products, the evaluation for reimbursement of medicines, or in an organisation interacting with regulatory agencies.
• Coordinating research projects or running clinical trials.
• Use of artificial intelligence in clinical developments.
• Extrapolating data from clinical studies to other populations, conditions, or products.
• The use of innovative methods for clinical evidence generation, e.g. Bayesian methods, complex trials.
• Methods relevant to trials for rare diseases.
• Pharmacometrics, modelling and simulation.
• Regulatory science.
• Working in a multidisciplinary team and in a multicultural environment.

Skills and knowledge

Project management methods.

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team.
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.).
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays).