Clinical Trials Data Management/Statistical Programming Specialist (Medtech)

TL;DR

Clinical Trials Data Management/Statistical Programming Specialist (Data Science/Biostatistics): Developing and validating statistical programs and data management processes for clinical study data to support regulatory decisions with an accent on CDISC standards implementation and TFL generation. Focus on building dynamic visualization tools and performing complex data analyses to assess medicine efficacy and safety.

Location: Amsterdam, The Netherlands (relocation is mandatory)

Salary: €5,979.74 net per month

Company

The European Medicines Agency (hirify.global) is a regulatory body that ensures all medicines available on the EU market are safe, effective, and of high quality.

What you will do

• Support business processes for the receipt, validation, characterization, and analysis of clinical study data submitted by developers.
• Create, validate, and execute code for clinical study data analyses to inform regulatory decision-making.
• Perform analyses of clinical study data and prepare reports consisting of tables, listings, and figures (TFLs).
• Validate clinical study data submissions to ensure strict adherence to CDISC standards, particularly ADaM and SDTM models.
• Collaborate with internal and external stakeholders, including Member States and pharmaceutical companies, on scientific and data aspects.
• Develop training and guidance materials for the use of clinical study data analysis tools across the EU regulatory network.

Requirements

• University degree in Data Science, Informatics, Computer Science, Engineering, Statistics, Mathhirify.globaltics, Biology, Medicines, or Pharmacy.
• At least 3 years of relevant professional experience after obtaining the degree.
• Full rights as a citizen of an EU Member State, Iceland, Liechtenstein, or Norway.
• English proficiency at C1 level and a satisfactory knowledge of another official EU language (B2).
• Proficiency in programming using statistical software such as R and/or SAS.
• Experience with CDISC standards (SDTM and ADaM models) and basic biostatistics.

Nice to have

• Completed PhD or Master's degree in the required fields.
• Experience with cloud technologies and AI technologies in data analytics frameworks.
• Track record in collaboration or publication on CDISC standards development.
• Experience with nonlinear mixed effects or mechanistic modelling software.
• Knowledge of model informed drug development (MIDD).

Culture & Benefits

• Initial 5-year renewable contract with competitive tax-free salary and allowances.
• Relocation assistance, expatriation and education allowances for eligible staff.
• Comprehensive health insurance scheme and retirement pension plan.
• Work-life balance with flexible working arrangements and teleworking options.
• Opportunity to work in a multinational and multidisciplinary environment contributing to public health.

Hiring process

• Preliminary assessment of application forms and eligibility criteria.
• Shortlisting based on pre-defined questions and competency scoring (0-10 points).
• Assessments including personality (OPQ32) and cognitive tests.
• Interviews to evaluate suitability and overall fit.