SNE/Biostatistician Specialist (evidence generation)

at  European Medicines Agency

Type of position: Seconded National Expert
Job title: SNE/Biostatistician Specialist (evidence generation)
Deadline for applications: 3 June 2024 at 23:59 CEST
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.
This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our Careers portal.
About this position
Provide biostatistical support for regulatory advice and assessment procedures concerning the development, authorisation and use of medicines. Additionally, contribute to international collaborations and strategic initiatives led by EMA.

In this post you will

• Support EMA’s scientific committees (e.g. CHMP, COMP, PDCO) and working parties (e.g. ONCWP, MWP, SAWP) on methodological aspects that contribute to scientifically sound and efficient drug development;
• Contribute to the development and coordination of scientific guidelines on the design and analysis of clinical studies;
• Advise companies developing medicines on the design, data collection, conduct, analysis and interpretation of clinical trials;
• Foster the development of training materials for the European Union Regulatory Network on assigned methodological subjects;
• Liaise 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 trials;
• Contribute to ongoing international collaborations and EMA projects and initiatives (e.g. EMA’s raw data project) as a leader, coordinator or subject matter expert.

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 (at least level B2);
• 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.

Managing resources
Plan most daily work details within given priorities. May have a direct supervision of one or more people performing related work. Work may include a degree of planning and coordination, including small projects.
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. 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 should 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.

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 or R;
• developing and delivering training on methodology for clinical trials.

SKILLS AND KNOWLEDGE

Sound knowledge and understanding of biostatistical concepts and techniques.
Nice to have

EDUCATION

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

EXPERIENCE

• In 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;
• In coordinating research projects. In developing and delivering training on methodology for observational data;
• In designing and conducting pharmacoepidemiological studies;
• In working in an Agile project;
• In working in a multidisciplinary team and in a multicultural environment.

SKILLS AND KNOWLEDGE

Project management methods
Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands
Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

Please refer the Job description for details