Principal Statistical Programmer (Remote) – SAS + R Expert

Colegio Oficial De Farmacéuticos De Cádiz; Cádiz; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with one of our pharmaceutical clients. The role combines independent program oversight with hands-on analytics, SDTM/ADaM, and regulatory deliverables.

You will lead CRO programming, develop reports, and ensure GCP compliance while collaborating with sponsors and vendors. A strong SAS background, CDISC expertise, and excellent communication are essential to succeed in this client-focused position.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma biometrics.
• Exceptional SAS programming skills with CDISC SDTM/ADaM/Define.xml experience.
• Regulatory submissions experience with FDA/ICH regulations.
• Ability to work independently with strong leadership.
• Excellent written and verbal communication.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality SAS/R programming results for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Follow FDA GCP and guidelines for electronic submissions.
• Create and maintain programming standards, tools, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, software vendors and clinical partners to meet project goals.
• Review and author SOPs / Work Instructions for statistical programming practices.

Skills

Leadership

Independent work

Communication

Regulatory experience

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with one of our pharmaceutical clients. The role combines independent program oversight with hands-on analytics, SDTM/ADaM, and regulatory deliverables.

You will lead CRO programming, develop reports, and ensure GCP compliance while collaborating with sponsors and vendors. A strong SAS background, CDISC expertise, and excellent communication are essential to succeed in this client-focused position.