Principal Statistical Programmer — Remote (SAS + R)

Nworld Advisory, Tech & Operations; Madrid; Remote; EUR 85,000 - 120,000; Full time

Job summary

Cytel Inc. in a remote role seeks a Senior/Principal Statistical Programmer to drive SDTM/ADaM, define.xml and data reporting for pharmaceutical development.

You will develop SAS programs, generate datasets and complex listings, and oversee CRO deliverables. The role requires 7+ years of Biotech/Pharma programming, strong CDISC experience, FDA/ICH familiarity, and independent work with clear communication and leadership.

Qualifications

• Minimum 7+ years as Statistical Programmer in Biotech/Pharma clinical development or similar.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/ICH.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings and tables, including complex graphs.
• Deliver high-quality programming results, validating and maintaining SAS and R programs for CDISC-compliant data.
• Oversee CRO programming deliverables across studies to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Independent work

Education

Bachelor's degree in computer science or related field

Tools

Unix/Linux

Git

Python

Shiny

Job description

Cytel Inc. in a remote role seeks a Senior/Principal Statistical Programmer to drive SDTM/ADaM, define.xml and data reporting for pharmaceutical development.

You will develop SAS programs, generate datasets and complex listings, and oversee CRO deliverables. The role requires 7+ years of Biotech/Pharma programming, strong CDISC experience, FDA/ICH familiarity, and independent work with clear communication and leadership.