Senior Statistical Programmer (SAS + R) – Remote

Iberian Sports Retail Group (Isrg); Santander; Remote; EUR 108,000 - 161,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a sponsor in clinical development. You will lead SAS and R programming for SDTM/ADaM, generate complex tables and listings, and oversee CRO deliverables across multiple studies.

You will deliver high-quality programming outputs for regulatory submissions, ensuring compliance with FDA/GCP guidelines and contributing to standards for programming tools and data validation plans.

Qualifications

• Senior-level statistical programming experience in clinical development
• Proficiency in SAS and R programming for datasets, listings and figures
• Experience delivering SDTM/ADaM specifications and output
• Ability to oversee CRO programmers and ensure high-quality timelines
• Knowledge of FDA/ICH/GCP guidelines and electronic submissions

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality statistical programming results with SAS and/or R programs
• Oversee CRO programmers and ensure timely, high-quality deliverables
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses
• Follow FDA regulations and GCP guidelines for reporting clinical trial data
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit checks, and data validation plans
• Coordinate with internal and CRO teams to meet project timelines

Skills

SAS programming

R programming

Statistical programming

SDTM

ADaM

CRO oversight

Tools

SAS

R

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a sponsor in clinical development. You will lead SAS and R programming for SDTM/ADaM, generate complex tables and listings, and oversee CRO deliverables across multiple studies.

You will deliver high-quality programming outputs for regulatory submissions, ensuring compliance with FDA/GCP guidelines and contributing to standards for programming tools and data validation plans.