Principal Statistical Programmer (SAS + R) - Remote

Seidor; Castro-Urdiales; Remote; EUR 70,000 - 95,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on sponsor-driven clinical development programs. The role involves leading programming activities across SDTM/ADaM, datasets, listings, and graphs, with oversight of CRO deliverables and regulatory submissions.

The candidate will develop, validate, and maintain SAS and R programs, support study reports, DSURs, and exploratory analyses while ensuring compliance with FDA guidelines and electronic submission

Qualifications

• Experience implementing SDTM/ADaM specifications.
• Proficient in SAS programming for datasets, tables, and graphs.
• Familiarity with FDA/regulatory guidelines for electronic submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables, and graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables for multiple studies to ensure high-quality and timely delivery
• Support the preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses
• Understand and follow FDA regulations affecting reporting of clinical trial data
• Contribute to creation and validation of standards for programming tools and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review

Skills

SAS programming

R programming

SDTM/ADaM

Clinical data submission

CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on sponsor-driven clinical development programs. The role involves leading programming activities across SDTM/ADaM, datasets, listings, and graphs, with oversight of CRO deliverables and regulatory submissions.

The candidate will develop, validate, and maintain SAS and R programs, support study reports, DSURs, and exploratory analyses while ensuring compliance with FDA guidelines and electronic submission