Lead Statistical Programmer (SAS/R) - Remote

Randstad; Córdoba; Remote; EUR 89,000 - 125,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely and be embedded with a pharmaceutical client. The role focuses on leading programming activities, SDTM/ADaM development, and collaboration with CROs to ensure high-quality data deliverables.

You will generate complex listings and graphs, support regulatory submissions, and ensure FDA/ICH compliance. A minimum of 7+ years in biotech/pharma programming is preferred.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development or similar.
• Exceptional SAS programming skills with CDISC standards (SDTM/ADaM) and regulatory submission experience.
• Experience supporting regulatory submissions and interactions with FDA/ICH authorities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality programming outputs, validate and maintain SAS/R programs for clinical development.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Ensure compliance with FDA regulations and GCP for electronic submissions.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulatory submissions

R programming

Leadership

Communication

Independent work

Data analysis

Education

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

Tools

SAS

Unix/Linux

Git

Define.xml tooling

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely and be embedded with a pharmaceutical client. The role focuses on leading programming activities, SDTM/ADaM development, and collaboration with CROs to ensure high-quality data deliverables.

You will generate complex listings and graphs, support regulatory submissions, and ensure FDA/ICH compliance. A minimum of 7+ years in biotech/pharma programming is preferred.