SNE/Biostatistician Specialist (evidence generation)

About this position

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

In this job you will

• 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;
• 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 the development, testing and utilisation of innovative methods for the design and analysis of clinical studies;
• 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.

Apply if you meet these eligibility criteria

1. Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;
2. 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);
3. Are currently 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.

Managing resources

Plan most daily work details within given priorities. 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.

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, Python or R;
•    Developing and delivering training on methodology for clinical trials.

Nice to have

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

Experience

Experience in the following areas would be desirable:

• 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
• Coordinating research projects or running clinical trials
• Use of artificial intelligence in clinical developments
• Extrapolating data from clinical studies to other populations, conditions, or products
• The use innovative methods for clinical evidence generation, e.g. Bayesian methods, complex trials
• Methods relevant to trials for rare diseases
• Pharmacometrics, modelling and simulation
• Regulatory science
• Working in a multidisciplinary team and in a multicultural environment.

Skills and knowledge
Project management methods