SNE/Biostatistician Specialist (Biostatistics)

TL;DR

SNE/Biostatistician Specialist (Biostatistics): Providing statistical expertise for the design and analysis of clinical studies to ensure scientifically sound evidence generation with an accent on regulatory submissions and clinical trial methodology. Focus on developing scientific guidelines, advising medicine developers, and collaborating with the academic community to implement innovative statistical methods.

Location: Amsterdam, Netherlands (Hybrid/Teleworking). Must be a citizen of an EU Member State, Iceland, Liechtenstein, Norway, Moldova, or Ukraine and currently employed in the public sector.

Company

The European Medicines Agency (hirify.global) is a decentralized body of the EU responsible for the evaluation and supervision of medicines to protect public health.

What you will do

• Support scientific committees and working parties on methodological aspects of evidence generation for efficient drug development.
• Develop and coordinate scientific guidelines for the design, conduct, and analysis of clinical studies.
• Advise pharmaceutical companies on data collection, trial conduct, and statistical analysis.
• Collaborate with academic and research organizations to test and utilize innovative methods for clinical studies.
• Lead and coordinate international collaborations and hirify.global projects, such as the clinical study data project.

Requirements

• EU, EEA, Moldova, or Ukraine citizenship.
• Current employment in the public sector of an EU Member State.
• University degree (3+ years) in Mathhirify.globaltics, Statistics, Epidemiology, Pharmacy, Medicine, or related scientific subjects.
• 3+ years of experience in clinical trial design, data analysis, or methodology training.
• Practical experience with statistical software such as SAS, Python, or R.
• English: C1 level required; satisfactory knowledge of another official EU language (B2).

Nice to have

• PhD or Master's degree in Mathhirify.globaltics, Statistics, or Epidemiology.
• Experience in regulatory environments, medicine authorization, or reimbursement evaluation.
• Knowledge of AI applications in clinical development or Bayesian methods.
• Expertise in pharmacometrics, modelling, and simulation.
• Experience with rare disease trials and multidisciplinary multicultural environments.

Culture & Benefits

• Meaningful work contributing to the health of every individual and animal in Europe.
• Flexible working arrangements, including teleworking and generous annual leave.
• Professional development opportunities through internal mobility, mentoring, and peer coaching.
• Relocation assistance and a comprehensive health insurance scheme.
• Competitive tax-free salary, household/children allowances, and a retirement pension plan.

Hiring process

• Initial assessment based on the application form.
• Interviews and potentially a written test to evaluate qualifications and suitability.
• Final recommendation by the Selection Committee to the Executive Director.