Senior Principal Statistical Programmer (SAS + R) Remote

The Door Talent; La Coruña; Remote; EUR 107,000 - 151,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated team, working fully embedded with one of our pharmaceutical clients.

You will deliver SDTM/ADaM specifications, develop SAS and R code, and supervise CRO programming to ensure high-quality data delivery in a fully remote setting. The role requires 7+ years in clinical programming, expert SAS, CDISC standards, and experience with regulatory submissions.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma clinical development or similar.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive experience with CDISC SDTM/ADaM and Define.xml.
• Experience with regulatory submissions and interacting with FDA/ICH.
• Ability to work independently and lead with strong communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality statistical programming results and validate SAS and/or R programs
• Oversee CRO programmers to meet timelines across studies
• Support clinical study reports, regulatory submissions, publications, and DSUR
• Follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Collaborate with CROs, vendors, and partners to meet project goals
• Create SOPs and work instructions for statistical programming practices

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership / communication

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Define.xml

SDTM/ADaM

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to join a sponsor-dedicated team, working fully embedded with one of our pharmaceutical clients.

You will deliver SDTM/ADaM specifications, develop SAS and R code, and supervise CRO programming to ensure high-quality data delivery in a fully remote setting. The role requires 7+ years in clinical programming, expert SAS, CDISC standards, and experience with regulatory submissions.