Senior/Principal Statistical Programmer (Clinical Statistical Programming)

Location: Remote within the European Union

Company

hirify.global is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead statistical programming activities across multiple clinical studies and compounds from study start-up through database lock, reporting, and regulatory submission.
• Develop, review, and validate tables, listings, figures, SDTM and ADaM datasets, Define-XML, and related documentation.
• Support global regulatory submissions and responses to health authority questions.
• Provide technical oversight for outsourced programming activities and ensure quality, budget, and timeline expectations are met.
• Develop and improve SAS programming standards, SOPs, work instructions, and best practices.
• Mentor statistical programmers and act as a subject matter expert across assigned studies and therapeutic areas.

Requirements

• 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
• Strong proficiency in SAS programming, including development, QC, validation, and documentation.
• Strong understanding and hands-on experience with CDISC, SDTM, ADaM, TFL programming, and clinical trial reporting.
• Experience with complex clinical trial data and study designs, regulatory submissions, and independent technical leadership across multiple studies.
• Bachelor’s or MSc degree in Statistics, Mathematics, or a scientific discipline.
• English is required.

Nice to have

• Experience in Oncology, Rare Disease, or Neuroscience.
• Experience with R or other statistical programming packages.
• Experience with NDA or sNDA submissions.
• French language skills.

Culture & Benefits

• Work directly for a single sponsor with the support and career opportunities of a global CRO.
• Access to continuous training and professional development.
• Work with more than 4,000 professionals across over 20 countries.
• Collaborative and inclusive environment focused on quality, compliance, and continuous improvement.