Senior Principal Statistical Programmer (SAS+R) – Remote

Kpmg España; Málaga; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer for a fully remote role within a sponsor-driven program. The role emphasizes autonomy, ownership, and delivering compliant SDTM/ADaM outputs across multiple studies.

You will develop SAS and R pipelines, oversee CRO deliverables, support regulatory submissions, and ensure alignment with FDA/EMA guidelines while collaborating with biostatistics and programming teams.

Qualifications

• Extensive experience in statistical programming for clinical development.
• Strong knowledge of SDTM/ADaM data structures and CSR support.
• Experience liaising with CROs and clinical vendors.
• Ability to work with minimal supervision on complex analyses.
• Familiarity with FDA/EMA regulations for submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results in SAS and/or R for development programs.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Understand and apply FDA regulations for reporting clinical trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specs for external vendors.
• Collaborate with internal and external partners to meet project goals.
• Provide SOPs/work instructions related to statistical programming practices.

Skills

Statistical programming

Clinical trials

SAS programming

R programming

Leadership / CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer for a fully remote role within a sponsor-driven program. The role emphasizes autonomy, ownership, and delivering compliant SDTM/ADaM outputs across multiple studies.

You will develop SAS and R pipelines, oversee CRO deliverables, support regulatory submissions, and ensure alignment with FDA/EMA guidelines while collaborating with biostatistics and programming teams.