Job grade: AD 6 Internal job grade: AD06 and above Type of position: Temporary agent Selection procedure reference: EMA/AD/11435 Job title: Clinical Trials Data management/Statistical Programming Specialist Talent Pool: AD06 Business & Data Intelligence Deadline for applications: 31 July 2026 at 23.59 CET Net Salary: 5.979,74 Euro (including local weighting) <a style="color:blue;text-decoration:underline" title="" href="#_ftn1" name="_ftnref1">[1]</a> plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week)) Location: Amsterdam; The Netherlands (relocation to take up duties is mandatory) XX<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 role</H2> </div><div>The European Medicines Agency (EMA) relies on the results of clinical studies conducted by medicines developers to inform its opinions on the authorisation of medicinal products. The clinical evidence is usually provided in the form of summary reports (clinical study reports) and in some cases complemented by line listings of individual patient-level clinical study data in pdf format. EMA and Heads of Medicines Agencies (HMA) recently started exploring the benefits of receiving, early in the evaluation of applications for marketing authorisations, individual patient-level data from clinical studies in electronic structured format. The aim is to deepen the regulators’ understanding in the evidence submitted to support these applications. Specifically, validation, characterisation and analyses of clinical study data are intended to help inform the assessment of efficacy and safety of new medicines, as well as pharmacokinetics (PK) and pharmacodynamics (PD), including modelling and simulation, and guide the selection of trial sites to verify compliance with Good Clinical Practice (GCP). To support this activity, EMA is looking for data management and statistical programming specialists experienced in the curation and management of clinical study data, and/or in the development of dynamic visualisation and analysis tools. To support this activity, EMA is looking for clinical trials data management/statistical programming specialists experienced in the curation and management of clinical study data, and/or in the development of dynamic visualisation and analysis tools. The role(s) defined in this procedure underpin the Network Data Steering Group’s (NDSG) objectives to strengthen data use and management in medicines regulation, in alignment with the European medicines agencies network strategy to leverage data and artificial intelligence in the regulation of human and veterinary medicines in the EU. ___________________________________________________________________________________ <a title="" href="https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/use-clinical-study-data-medicine-evaluation" target="_self">Use of clinical study data in medicine evaluation | European Medicines Agency (EMA)</a> <a href="https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/network-data-steering-group-ndsg">Network Data Steering Group (NDSG) | European Medicines Agency (EMA)</a> <a href="https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-final_en.pdf">The European medicines agencies network strategy 2028</a></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>As a specialist in Data Science, you will be involved in several data management, data science and related activities. The main activities include: As a specialist in statistical programming for clinical trials, you will contribute to a wide range of activities, including data validation, data management, data analysis and other related tasks. Your key responsibilities will include: • Support business processes’ development for the receipt, validation, characterisation, analysis, and visualisation of clinical study data submitted to the Agency by medicines developers; • Support the use of data analysis programmes and tools by creating, validating, executing and generating code for clinical study data analyses to answer questions relevant to regulatory decision making; • Perform analyses of clinical study data to support evaluations of marketing authorisation applications and prepare analysis reports consisting of tables, listings and figures (TFLs); • Support validation of clinical study data submissions to ensure adherence to CDISC standards, particularly ADaM and SDTM models; • Manage the quality and robustness of data according to the Agency’s data governance framework; • Develop training on the use of clinical study data analysis programmes and tools, and support knowledge sharing activities across the EU medicines regulatory network; • Develop guidance on the submission, validation, characterisation, analysis and visualisation of clinical study data for medicine developers and regulatory assessors; • Provide data management and analytics input aiming to deliver and maintain IT solutions to support the receipt, validation, characterisation, analysis, and visualisation of clinical study data; • Collaborate and communicate on scientific and data aspects of the work performed and on the Agency’s position on scientific and medicinal product issues with internal and external stakeholders (Member States, academic institutions, pharmaceutical companies, European and international organisations and other relevant stakeholders), including preparation and delivery of presentations and publications; • Contribute to the planning, the organisation, the running and in summarising of scientific meetings and workshops; • Work in a multicultural environment with multidisciplinary teams. Link to the full role description of the <a title="" href="https://www.ema.europa.eu/en/documents/recruitment/role-description-data-science-specialist_en.pdf" target="_self">Data Scientist Specialist</a> outlining generic duties and responsibilities.</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>General conditions: 1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway; 2. 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); 3. have fulfilled any obligations imposed by applicable laws concerning military service. Specific conditions: 1. possess a university degree of a minimum of three years or more in Data Science, Informatics, Computer Science, Engineering, Statistics, Mathematics, Biology, Medicines, or Pharmacy or other fields of science that require advanced use of analytics skills, that must have been obtained by the closing date of this vacancy notice; 2. have at least 3 years of relevant professional experience after obtaining the relevant degree and before the closing date of this vacancy notice. General Condition 1 and Specific Conditions will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result in the disqualification from the selection procedure. Only eligible candidates will be assessed by the selection committee.</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">You will need</H2> </div><div><ul> <li>General understanding of medicines development and design / execution of clinical trials </li> <li>Competency in Data Management including understanding, manipulation, cleansing and validation of clinical study data as per CDISC standards; and/or </li> <li>Competency in Data analytics, specifically in Statistical Programming including development, validation and maintenance of statistical programs for the analysis of clinical study data </li> </ul> Proven experience in the following: <ul> <li>Programming using statistical software (R and/or SAS) and development of dynamic data visualisation tools (e.g.. via R Shiny); </li> <li>Experience in preparing reports consisting of narratives, tables, listing and figures summarising clinical study data analyses; </li> <li>Working with clinical trial structured datasets as per CDISC standards such as SDTM and ADaM models and accompanied metadata; </li> <li>Exposure to basic biostatistics </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">Competencies you need to have:</H2> </div><div>Sub-family competencies Data management (please see specific expectations listed under “You will need section”) Advanced Data analytics (please see specific expectations listed under “You will need section”) Intermediate Applied knowledge Intermediate Grade competencies Adaptability and agility Intermediate Analysing and problem solving Intermediate Prioritising and organising Intermediate Core competencies 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 For more information about definitions of competencies and associated proficiency levels, please refer to the <a title="" href="https://www.ema.europa.eu/en/documents/recruitment/ema-competency-framework_en.pdf" target="_self">EMA Competency Framework</a>.</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">These are considered as nice to have:</H2> </div><div>Education Completed PhD or master’s degree in one of the university degrees required for eligibility. Experience It will be of advantage if you have: <ul> <li>a track record in collaboration/publication on development or implementation of CDSIC standards </li> <li>developed training and guidance materials; </li> <li>worked in data analytics frameworks based on cloud technologies and/or AI technologies; </li> <li>designed and written macros; </li> <li>worked in a team and in a multicultural and multi-disciplinary environment; </li> <li>worked with nonlinear mixed effects and/or mechanistic modelling software; </li> <li>experience in model informed drug development (MIDD). </li> </ul></div></div></div>Selection procedure timelines <table class="Table" style="width:26%;height:166.979px" align="left"> <tbody> <tr style="height:55.6597px"> <td style="padding:0.1px;width:52%"> Deadline for applications </td> <td style="padding:0.1px;width:48%"> 31 July 2026 at 23.59 CET </td> </tr> <tr style="height:55.6597px"> <td style="padding:0.1px;width:52%"> Preliminary Assessments </td> <td style="padding:0.1px;width:48%"> Mid August 2026 </td> </tr> <tr> <td style="padding:0.1px;width:52%"> Final Assessments </td> <td style="padding:0.1px;width:48%"> 2nd week of September 2026 </td> </tr> <tr style="height:55.6597px"> <td style="padding:0.1px;width:52%"> Decision expected </td> <td style="padding:0.1px;width:48%"> End of September 2026 </td> </tr> </tbody> </table> Selection process Only eligible candidates (see eligibility criteria) will be assessed by the selection committee. Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure. Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family, Grade Specific competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria. Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the <a href="https://www.ema.europa.eu/en/documents/recruitment/careers-european-medicines-agency-ema-guidance-selection-recruitment_en.pdf#page=7&zoom=100,80,641">Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure)</a> for an overview of the criteria and competences assessed at each stage of the process. Shortlisting In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria and sub-family competences. The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form. To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice. Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the <a href="https://www.ema.europa.eu/en/documents/recruitment/careers-european-medicines-agency-ema-guidance-selection-recruitment_en.pdf#page=12&zoom=100,80,776">Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments)</a> for an overview of the thresholds. Assessments Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice. Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process. Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed. Please consult the <a href="https://www.ema.europa.eu/en/documents/recruitment/careers-european-medicines-agency-ema-guidance-selection-recruitment_en.pdf#page=7&zoom=100,80,641">Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure)</a> for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.X Reserve list and/or job offers The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer. We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency. When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview. More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our <a href="https://careers.ema.europa.eu/content/Application-process-for-Temporary-Agents-and-Contract-Agents/?locale=en_GB">careers website</a>. If Temporary Agent posts are not available, if justified in the interest of the service, candidates on the reserve list may be approached to provide written consent to be considered for Contract Agent positions. These candidates will remain on the Temporary Agent reserve list and will be considered for a Temporary Agent post should a suitable post become available. Contract Agent posts differ from Temporary Agent posts in terms of categories, function groups, grades and remuneration and career progression.X Conditions of employment In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates. The successful candidate will be required to relocate to the Netherlands to pick up duties. <div><hr align="left" size="1" width="33%"></div> <a name="_ftn1"></a><a href="#_ftnref1">[1]</a> The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the <a href="http://ec.europa.eu/eurostat/web/civil-servants-remuneration/correction-coefficients" target="_blank" rel="noopener">Eurostat</a> and <a href="https://myintracomm.ec.testa.eu/hr_admin/en/pay/Pages/corr_coeff.aspx" target="_blank" rel="noopener">Commission</a> websites for more information on weightings. ______________________________________________________________________________________________________ Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands Telephone +31 (0)88 781 6000 - Email <a href="mailto:[email protected]">[email protected]</a> © European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.

Clinical Trials Data management/Statistical Programming Specialist (EMA Amsterdam, 11435, NL) @ European Medicines Agency

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