Principal Statistical Programmer (Remote) - SAS + R

RubyPlay; Islas Baleares; Remote; EUR 85,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work fully embedded with a pharmaceutical client. You will independently lead programming activities across SDTM/ADaM, develop datasets, listings, and graphs, and oversee CRO deliverables to ensure high quality on timelines.

Role requires extensive CDISC experience, regulatory submission involvement, and strong communication. Remote work within a Cytel sponsorship framework is offered.

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 for clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interacting with FDA/global authorities.

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 SAS and R programs tailored to trial needs.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review/author data transfer specs for external data.

Skills

SAS programming

Statistical programming

CDISC SDTM/ADaM

FDA/ICH compliance

Independent work

Leadership

Regulatory submissions

Communication skills

Education

Bachelor's degree

Tools

SAS

R

Python

Unix/Linux

Git

Shiny

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work fully embedded with a pharmaceutical client. You will independently lead programming activities across SDTM/ADaM, develop datasets, listings, and graphs, and oversee CRO deliverables to ensure high quality on timelines.

Role requires extensive CDISC experience, regulatory submission involvement, and strong communication. Remote work within a Cytel sponsorship framework is offered.