Principal Statistical Programmer (SAS + R) - Remote

La Casa de las Carcasas France; Cáceres; Remote; EUR 60,000 - 95,000; Full time

Job summary

Cytel invites applications for a Senior/Principal Statistical Programmer SAS + R (Remote). You will be dedicated to a global pharmaceutical client, providing expert programming support across SDTM/ADaM specifications, datasets, and create reviewer's guides and define.xml.

As a Principal Statistical Programmer you will work largely independently, oversee CRO programmers, deliver high-quality analyses, and contribute to regulatory submissions while complying with FDA guidelines and GCP.

Qualifications

• Senior statistical programmer with experience in clinical trials.
• Experience with SDTM/ADaM specs and regulatory submissions.
• Experience supervising CROs and coordinating programming deliverables.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS and R programming outputs for development programs.
• Oversee CRO programming deliverables and ensure timelines are met.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Ensure compliance with FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in development of CRFs, edit check specifications, and data validation plans.
• Provide review.

Skills

SAS programming

R programming

SDTM/ADaM specifications

Regulatory knowledge (FDA/gCP)

Team leadership/mentoring

Tools

SAS

SAS Studio

R

Job description

Cytel invites applications for a Senior/Principal Statistical Programmer SAS + R (Remote). You will be dedicated to a global pharmaceutical client, providing expert programming support across SDTM/ADaM specifications, datasets, and create reviewer's guides and define.xml.

As a Principal Statistical Programmer you will work largely independently, oversee CRO programmers, deliver high-quality analyses, and contribute to regulatory submissions while complying with FDA guidelines and GCP.