Principal Statistical Programmer (SAS & R) - Remote

Iberian Sports Retail Group (Isrg); Valladolid; Remote; EUR 60,000 - 90,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to support sponsor clinical development programs. You will work with SAS and R, develop SDTM/ADaM specifications, datasets, listings and figures, and oversee CRO programmers to ensure high-quality deliverables.

You will operate with minimal supervision, ensure regulatory alignment with FDA guidelines, contribute to study reports and submissions, and help maintain standards for programming tools and workflows across studies.

Qualifications

• Extensive experience in SDTM/ADaM specifications and programming.
• Regulatory submissions experience and familiarity with FDA guidelines.
• Ability to oversee CROs and ensure data quality across studies.
• Strong independent work style with minimal supervision.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, listings, tables and complex graphs
• Deliver high-quality statistical programming results including SAS and/or R programs
• Oversee CRO's statistical programming deliverables across studies
• Support preparation of study reports, regulatory submissions, publications and DSUR
• Follow FDA regulations and good clinical practice for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Participate in development of CRFs, edit checks and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet timelines

Skills

SAS

R

Clinical trials

Data analysis

Tools

ADaM

SDTM

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to support sponsor clinical development programs. You will work with SAS and R, develop SDTM/ADaM specifications, datasets, listings and figures, and oversee CRO programmers to ensure high-quality deliverables.

You will operate with minimal supervision, ensure regulatory alignment with FDA guidelines, contribute to study reports and submissions, and help maintain standards for programming tools and workflows across studies.