Cencora seeks a Senior Statistical Programmer with deep CDISC expertise to lead statistical programming activities and serve as a subject matter expert in data standards. The role involves developing compliant datasets, managing regulatory submissions, and coordinating programming projects across internal and external teams.
Responsibilities
- Lead development, review, and documentation of CDISC-compliant dataset specifications with focus on SDTM and ADaM standards
- Perform quality control of CDISC specifications, derived datasets, and tables, figures, and listings for compliance and quality
- Generate or review TFLs for clinical study reports and prepare submission-ready regulatory documentation
- Perform statistical programming in SAS and R ensuring compliance with CDISC standards and regulatory guidelines
- Support process optimization, develop programming infrastructure,



and provide technical training to team members

Requirements
- Master's degree in Statistics, Biostatistics, Data Science, or related field with 6+ years of clinical statistical programming experience
- Expert-level SAS proficiency for SDTM and ADaM dataset development from raw clinical data
- Proven experience preparing regulatory submissions including SDTM/ADaM datasets, Define.xml, SDRG, and ADRG
- Strong knowledge of CDISC Implementation Guides and FDA/EMA regulatory expectations
- Demonstrated experience creating macro libraries, format catalogs, SOPs, and submission documentation
- Strong project management, written and verbal communication skills with ability to manage multiple stakeholders

📌 Senior Statistical Programmer (España)
🏢 Cencora
📍 España