Principal Statistical Programmer (SAS + R) – Remote

GrupoSC Distribuidora de Medicamentos; Madrid; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-driven global clinical development program. You will generate SDTM and ADaM specifications, develop SAS and R programs, and oversee CRO work to ensure high-quality data deliverables.

The role requires extensive CDISC experience, regulatory submissions, and strong independent work and leadership skills. FDA/GCP familiarity is essential; flexibility for international collaboration is preferred.

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 in a clinical development environment.
• Extensive CDISC (SDTM/ADaM/Define.xml) experience and regulatory submissions.
• Ability to work independently; strong communication and leadership.
• Nice to have experience in R, Python, Java, Shiny, Unix/Linux and git.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewers' guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and complex graphs.
• Deliver high-quality SAS and/or R programs tailored to development needs.
• Oversee CRO programming deliverables to meet timelines and quality.
• Support preparation of CSR, regulatory submissions, publications and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards, tools, macros documentation and validation.
• Assist in CRF development, edit checks and data validation plans.
• Provide data transfer specs for external vendors.
• Collaborate with CROs, vendors and partners to meet project goals.
• Review and author SOPs or Work Instructions for statistical programming.

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Communication skills

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

R

Python

Java

Shiny

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-driven global clinical development program. You will generate SDTM and ADaM specifications, develop SAS and R programs, and oversee CRO work to ensure high-quality data deliverables.

The role requires extensive CDISC experience, regulatory submissions, and strong independent work and leadership skills. FDA/GCP familiarity is essential; flexibility for international collaboration is preferred.