Clinical Trials Data management/Statistical Programming Specialist

At the European Medicines Agency (EMA), this role supports the use of clinical study data in the evaluation of medicines and helps strengthen data use and management in medicines regulation across the EU.

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) have 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 regulators’ understanding of 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 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 underpins 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.

About this role

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, organisation, running and summarising of scientific meetings and workshops;
• Work in a multicultural environment with multidisciplinary teams.

Eligibility criteria

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;
2. Have at least 3 years of relevant professional experience after obtaining the relevant degree.

What you will need

• General understanding of medicines development and design/execution of clinical trials;
• Competency in Data Management including understanding, manipulation, cleansing and validation of clinical study data as per CDISC standards; and/or
• Competency in Data analytics, specifically in Statistical Programming including development, validation and maintenance of statistical programs for the analysis of clinical study data.

Proven experience in the following:

• Programming using statistical software (R and/or SAS) and development of dynamic data visualisation tools (e.g. via R Shiny);
• Experience in preparing reports consisting of narratives, tables, listings and figures summarising clinical study data analyses;
• Working with clinical trial structured datasets as per CDISC standards such as SDTM and ADaM models and accompanied metadata;
• Exposure to basic biostatistics.

Competencies

Sub-family competencies

• Data management — Advanced
• Data analytics — 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

Nice to have

Education

Completed PhD or master’s degree in one of the university degrees required for eligibility.

Experience

• A track record in collaboration/publication on development or implementation of CDISC standards;
• Developed training and guidance materials;
• Worked in data analytics frameworks based on cloud technologies and/or AI technologies;
• Designed and written macros;
• Worked in a team and in a multicultural and multi-disciplinary environment;
• Worked with nonlinear mixed effects and/or mechanistic modelling software;
• Experience in model informed drug development (MIDD).

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to candidates. The successful candidate will be required to relocate to the Netherlands to take up duties.

Working at EMA

Serving a population of 500 million citizens, we promote and protect public animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

What EMA offers:

• 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)
• Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan