Principal Statistical Programmer (SAS+R) – Remote

Thedoortalent; La Coruña; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven projects within the pharmaceutical sector. You will lead statistical programming activities, generate SDTM/ADaM outputs, and supervise CRO deliverables while ensuring regulatory compliance and data quality.

Ideal candidates have 7+ years of experience in biotech/pharma biometrics, strong SAS skills, and CDISC expertise, with the ability to work independently in a global team.

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 biometrics.
• Exceptional SAS programming skills with CDISC standards (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/ICH.
• Ability to work independently and lead CRO programming deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Adhere to FDA regulations and GCP for reporting of trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal and external functions to meet project goals.
• Review/author SOPs and work instructions for statistical programming practices.

Skills

SAS programming

Leadership

Communication skills

Independent work

CDISC SDTM/ADaM

Regulatory submissions

Clinical development

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-driven projects within the pharmaceutical sector. You will lead statistical programming activities, generate SDTM/ADaM outputs, and supervise CRO deliverables while ensuring regulatory compliance and data quality.

Ideal candidates have 7+ years of experience in biotech/pharma biometrics, strong SAS skills, and CDISC expertise, with the ability to work independently in a global team.