Lead Statistical Programmer — SAS/R, Remote

Iqvia; Santiago de Compostela; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Equal Employment Opportunity

Job summary

Cytel is hiring a Senior/Principal Statistical Programmer (Remote) to work with sponsor clients within a dedicated Cytel program. The role focuses on independent, expert SAS/R programming for multiple clinical studies, with CRO oversight and regulatory submission support.

The candidate will develop SDTM/ADaM specifications, datasets, tables, and graphs, while ensuring FDA/ICH compliance and high-quality outputs across therapeutic areas.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills with CDISC (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and interacting with FDA/ICH authorities.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies (<140 chars).
• Develop SAS programs to create datasets, listings, tables and graphs for clinical trials.
• Oversee CRO programmers to ensure timely, high-quality outputs.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Ensure compliance with FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Assist in CRF development, edit checks and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and development partners to meet timelines.
• Develop SOPs and work instructions for programming practices.

Skills

SAS programming

R

CDISC standards

FDA/ICH regulation

Regulatory submissions

Independent work

Leadership

Education

Bachelor's degree in CS/Data Science/Math/Stats

Tools

SAS

R

Python

Unix/Linux

git

Shiny

Job description

Cytel is hiring a Senior/Principal Statistical Programmer (Remote) to work with sponsor clients within a dedicated Cytel program. The role focuses on independent, expert SAS/R programming for multiple clinical studies, with CRO oversight and regulatory submission support.

The candidate will develop SDTM/ADaM specifications, datasets, tables, and graphs, while ensuring FDA/ICH compliance and high-quality outputs across therapeutic areas.