Biostatistician Specialist - Evidence Generation

4w1 month ago

European Medicines Agency

Amsterdam, NL · Full-time · €55,000 – €75,000

About this role

The European Medicines Agency (EMA) is a decentralized body of the European Union based in Amsterdam, responsible for protecting and promoting public health through the evaluation and supervision of medicines. We are seeking a National Expert on Secondment (SNE) to serve as a Biostatistician Specialist in evidence generation.

In this role, you will provide statistical expertise to the design, conduct, and analysis of clinical studies and the interpretation of study results within regulatory submissions. You will support EMA's scientific committees and working parties on methodological aspects that contribute to scientifically sound evidence generation and efficient drug development.

You will contribute to the development and coordination of scientific guidelines on clinical study design, conduct, analysis, and interpretation, and advise companies developing medicines on trial design and data collection. You will also foster training materials for the EU Regulatory Network and engage with academic communities to advance innovative methods.

As an SNE, you bring your expertise to EMA and take back knowledge to your home administration, enhancing collaboration between European public administrations. Secondment periods last between six months and two years, renewable up to a total of four years, while you remain employed by your home public-sector employer.

Requirements

Enjoy full rights as a citizen of an EU Member State, Iceland, Liechtenstein, 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)
Currently employed in the public sector (e.g., public intergovernmental organisation, national/regional/local public administration) in an EU Member State and remain in such employment for the foreseen duration of secondment
Advanced degree in biostatistics, statistics, or a related quantitative field
Proven expertise in biostatistical methods for clinical trial design, conduct, and analysis
Experience with regulatory submissions and scientific advice procedures in the pharmaceutical sector
Knowledge of the EU regulatory framework for medicines and clinical trial methodology

Responsibilities

Support the Agency and its scientific committees (e.g., CHMP, COMP, PDCO) and working parties on methodological aspects for evidence generation and 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 innovative methods for clinical study design and analysis
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

Benefits

Opportunity to work at the European Medicines Agency in Amsterdam, a decentralized body of the European Union
Secondment period of 6 months to 2 years, renewable up to a total of 4 years
Enhance and develop the relationship between European public administrations through knowledge exchange
Bring your expertise to EMA and take back valuable knowledge and experience to your home administration
Remain employed by your home public-sector employer throughout the secondment period