Senior Statistical Programmer (CDISC)

Location: Spain, Portugal or Poland; available locations include Madrid, Warsaw, and Lisbon.

Company

hirify.global, affiliated with Cencora, operates in the pharmaceutical and biotechnology industry, supporting clinical trials, regulatory submissions, healthcare research, and strategic consulting.

What you will do

• Lead and contribute to CDISC-compliant dataset specifications and datasets, primarily SDTM and ADaM, and serve as a CDISC standards subject matter expert.
• Perform quality control of dataset specifications, derived datasets, and standard or custom tables, figures, and listings.
• Generate or review TFLs for clinical study reports and regulatory submissions using SAS and R.
• Prepare submission-ready Define.xml, SDRG, ADRG, ISS/ISE, and related documentation aligned with FDA and EMA expectations.
• Optimize programming processes through SAS macro libraries, templates, SOPs, R adoption, automation, AI integration, and internal training.
• Coordinate work across internal and external teams, validate colleagues' code, resolve data issues with statisticians and Data Management, and maintain quality and timelines.

Requirements

• Master’s degree in Statistics, Biostatistics, Data Science, or a related quantitative field with 6+ years of clinical statistical programming experience, or a Bachelor’s degree in the same fields with 8+ years of experience.
• Experience in the pharmaceutical, biotechnology, or CRO industry with hands-on regulatory submission work.
• Expert-level SAS programming and CDISC expertise, including SDTM and ADaM dataset development from raw clinical data and knowledge of SDTMIG and ADaMIG.
• Experience supporting eCTD submissions, including SDTM/ADaM datasets, Define.xml, SDRG, ADRG, TFLs, and submission documentation aligned with FDA and EMA expectations.
• Experience creating macro libraries, format catalogs, enhanced visual output displays, training presentations, SOPs, and related documentation.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Excellent organizational, project management, written, verbal, communication, problem-solving, and interpersonal skills.
• Ability to manage multiple projects, meet deadlines, work across clinical development phases, adapt to change, and collaborate with diverse internal and external stakeholders.
• Advanced SAS programming is required; proficiency or active development in R is strongly preferred.

Nice to have

• Primary-author experience with SDSP, SDRG, or ADRG beyond execution-level contribution.
• Cross-study data integration experience, including ISS/ISE, and experience with SEND.
• Experience working with international teams remotely.
• Management or Agile/Scrum experience.
• Statistical background or knowledge.

Culture & Benefits

• Full-time position with benefits aligned to local market practice outside the US.
• Benefit eligibility and effective dates may vary by country and may be affected by collective bargaining agreements.
• Work involves collaboration across internal and external teams and participation in task forces and initiatives.
• Equal employment opportunity and reasonable accommodation are provided in accordance with applicable legal requirements.