Senior Statistical Programmer: SAS + R, Remote

Deel; Barcelona; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, delivering SDTM/ADaM specifications and SAS/R programming.

The role includes supervising CRO programmers, developing datasets, listings, tables, and figures, and supporting regulatory submissions and study reports. Requires 7+ years in biostatistics programming, CDISC standards, FDA/ICH familiarity, and strong communication and leadership.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC standards knowledge (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently and lead teams.
• Excellent written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and complex graphs.
• Deliver high-quality SAS/R programs for clinical programs across therapeutic areas.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR analyses.
• Adhere to FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specs for external vendor data.
• Collaborate with CROs and vendors to meet project timelines.
• Assist in writing SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Vendor oversight

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

Unix/Linux

Git

Python

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, delivering SDTM/ADaM specifications and SAS/R programming.

The role includes supervising CRO programmers, developing datasets, listings, tables, and figures, and supporting regulatory submissions and study reports. Requires 7+ years in biostatistics programming, CDISC standards, FDA/ICH familiarity, and strong communication and leadership.