About this role
<p><span style="font-size:10.0pt"><span style="font-family:Verdana, Geneva, sans-serif"><strong>Type of position:</strong> Seconded National Expert<br><strong>Reference:</strong> EMA/SNE/11492</span> </span><br><span style="font-size:10.0pt"><span style="font-family:Verdana, Geneva, sans-serif"><strong>Job title: SNE/Biostatistician Specialist (evidence generation)</strong></span> </span><br><span style="font-size:10.0pt"><span style="font-family:Verdana, Geneva, sans-serif"><strong>Deadline for applications: 15 July 2026 at 23.59 CET</strong></span> <span style="font-family:Verdana, Geneva, sans-serif"><strong> </strong></span></span></p> <p> </p> <p><span style="font-size:10.0pt">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.</span></p> <p> </p> <p><span style="font-size:10.0pt">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.</span></p> <p> </p> <p><span style="font-size:10.0pt">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.</span></p> <p> </p> <p><span style="font-size:10.0pt"><span style="font-family:Verdana, Geneva, sans-serif">This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our <a>Careers portal.</a></span></span></p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">About this position</H2> </div><div><p><span style="font-size:10.0pt">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</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">In this job you will</H2> </div><div><ul> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Support the Agency and it’s 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;</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">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;</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Foster the development of training materials for the EU Regulatory Network on assigned methodological subjects;</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">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;</span></li> <li><span style="font-size:10.0pt"><span>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.</span> </span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Apply if you meet these eligibility criteria</H2> </div><div><ol style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">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);</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">Are current</span>ly employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional /local public administration) in an EU Member State and are due to remain in such employment for the foreseen duration of the SNE position.</li> </ol></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Managing resources</H2> </div><div><p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">Work may include a degree of planning and coordination, including small projects, in alignment with given priorities.</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Communication and professional contacts</H2> </div><div><p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">The position requires </span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">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;</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature;</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">engaging professionally with others inside and/or outside the Agency on functional matters;</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">soliciting/giving information, providing advice/guidance and using initiative to address tasks.</span></li> </ul> <p style="margin:0.0cm 0.0cm 0.0cm 36.0pt;font-size:9.0pt;font-family:Verdana, sans-serif"> </p> <p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">In particular, a Biostatistician Specialist will:</span></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">Present on behalf of the Agency externally on biostatistical and methodological topics of importance to the Agency and Network;</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:10.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt">Represent the Agency and wider Network on external scientific groups.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Essential requirements</H2> </div><div><p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt"><strong>Education</strong></span><br><span style="font-size:10.0pt">A level of education which corresponds to completed university studies of at least three years attested by a diploma;</span><br><span style="font-size:10.0pt">Field of study:</span><br><span style="font-size:10.0pt">Mathematics, statistics, epidemiology, pharmacy, medicine, or related scientific subjects.</span></p> <p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><br><span style="font-size:10.0pt"><strong>Experience </strong></span><br><span style="font-size:10.0pt">3 years from the time when a university degree was awarded on completion of a minimum of three years of study;</span><br><span style="font-size:10.0pt">Proven experience in at least one of the following:</span><br><span style="font-size:10.0pt">• Designing and conducting clinical trials including operational work in protocol development, trial conduct and data analysis, interpretation and reporting;</span><br><span style="font-size:10.0pt">• Managing, transforming and analysing clinical trial data, with practical use of statistical software like SAS, Python or R;</span><br><span style="font-size:10.0pt">• Developing and delivering training on methodology for clinical trials.</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Nice to have</H2> </div><div><p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt"><strong>Education </strong></span><br><span style="font-size:10.0pt">Completed PhD or master’s degree in mathematics, statistics or epidemiology.</span></p> <p><span style="font-size:10.0pt"><strong>Experience</strong></span></p> <p><span style="font-size:10.0pt">Experience in the following areas would be desirable:</span></p> <ul> <li style="font-size:10.0pt"><span style="font-size:10.0pt">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</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Coordinating research projects or running clinical trials</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Use of artificial intelligence in clinical developments</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Extrapolating data from clinical studies to other populations, conditions, or products</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">The use innovative methods for clinical evidence generation, e.g. Bayesian methods, complex trials</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Methods relevant to trials for rare diseases</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Pharmacometrics, modelling and simulation</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Regulatory science</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt">Working in a multidisciplinary team and in a multicultural environment.</span></li> </ul> <p style="margin:0.0cm;font-size:9.0pt;font-family:Verdana, sans-serif"><span style="font-size:10.0pt"><strong>Skills and knowledge</strong></span><br><span style="font-size:10.0pt">Project management methods </span></p></div></div></div><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>Timelines</strong></span></span></p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Deadline for applications 15 July 2026 23:59 CET <br>Interviews From 20 July 2026<br>Decision expected 31 July 2026 </span></span></p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"> <br><strong>Process</strong><br>This post is published in line with Chapter II Art 4 of EMA/329753/2015 (European Medicines Agency Decision of 30 June 2015 laying down general implementing provisions on the procedure governing the engagement and use of temporary staff under Article 2(f) of the Conditions of Employment of Other Servants of the European Union).</span></span></p> <p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">The process will follow Annex I of Guidance on Internal Talent Marketplace. </span></span></p> <p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Only eligible candidates (see eligibility criteria (i.e. temporary staff 2(f) who, on the closing date for applications and on the day of filling the post, are engaged within the agency in the function group and grade belonging to the grade bracket indicated in the internal publication.) will be assessed further. </span></span></p> <p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">The assessment of qualifications and suitability will be based solely on the required competencies, skills, knowledge, qualifications and experience for the role as stated in the internal publication.</span></span></p> <p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><u>Shortlisting</u><br>Talent Acquisition may publish additional pre-screening questions but, normally, the initial assessment will be conducted based on the application form submitted for an opening, and all eligible staff will be invited for a follow up assessment<br><u>Assessments</u><br>The assessments will include at the very least interviews and, only in specific circumstances, a written test, to identify the most suitable candidate. <br>In case of Head of Service roles, personality assessment or assessment of managerial competencies via assessment centre will be conducted.<br><u>Job offers</u><br>This publication is intended to fill a specific vacancy(ies), therefore, as a result of the assessments, the Selection Committee will recommend to the Executive Director the best candidate for the appointment, plus it may recommend 2-3 alternates from among those were found qualified and suitable for the specific vacancy in question. An additional interview with the hiring entity may be arranged before the final decision to recruit the candidate. Alternate candidates may be offered a position in case the initially selected candidate cannot take up the offer or their employment is not confirmed after probation period, but they are not placed in any reserve list. Alternate candidates may be appointed to other similar vacant post based on Art 7 of Staff Regulations.<br>The selected candidate, as well as all alternates, will be informed accordingly of the result of the internal publication.<br><u>Conditions of employment</u><br>The selected member of temporary staff 2(f) shall be assigned to the new post by written decision of the Executive Director without impact on his/her current contract of employment with the agency.</span></span></p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">______________________________________________________________________________________________________<br>Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands<br>Telephone +31 (0)88 781 6000 - Email [email protected]</span></span></p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.</span></span></p>