Principal Statistical Programmer - Remote (SAS/R)

Fever; Madrid; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel Senior/Principal Statistical Programmer SAS + R (Remote) role embedded with a global pharmaceutical client. You will lead programming for SDTM/ADaM specs, develop SAS/R programs, and oversee CRO deliverables, ensuring regulatory compliance and timely submissions.

You will work independently with minimal supervision, mentor junior staff, and contribute to study reports, DSURs, and regulatory documents while upholding FDA/ICH guidelines. A strong background in CDISC standards is essential.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team
• Exceptional SAS programming skills and experience implementing SDTM/ADaM/Define.xml
• Experience supporting regulatory submissions and interacting with FDA/ICH regulators
• Ability to work independently with minimal supervision
• Strong written and verbal communication and leadership skills
• Experience with pharmacokinetic data and neuroscience is a plus

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables and graphs
• Deliver high-quality programming results and maintain SAS/R programs
• Oversee CRO programming deliverables and timelines
• Support preparation of clinical study reports, regulatory submissions, DSURs
• Ensure compliance with FDA regulations and GxP guidelines
• Contribute to standards development for tools, outputs, and validation
• Draft data transfer specs and collaborate with CROs and vendors

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory filings (FDA/ICH)

Independent work

Leadership

Communication skills

CRO oversight

SAS & R

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Java

Shiny

Markdown

Job description

Cytel Senior/Principal Statistical Programmer SAS + R (Remote) role embedded with a global pharmaceutical client. You will lead programming for SDTM/ADaM specs, develop SAS/R programs, and oversee CRO deliverables, ensuring regulatory compliance and timely submissions.

You will work independently with minimal supervision, mentor junior staff, and contribute to study reports, DSURs, and regulatory documents while upholding FDA/ICH guidelines. A strong background in CDISC standards is essential.