Remote Principal Statistical Programmer (SAS + R)

Minsait; Gijón; Remote; EUR 70,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team working with a global pharmaceutical client. You will lead programming activities, ensure data quality, and contribute to regulatory submissions.

Responsibilities include generating SDTM/ADaM specs, developing SAS and R programs, overseeing CRO deliverables, and aligning with FDA guidelines for submissions.

Qualifications

• Extensive experience in clinical trial programming and data handling.
• Strong knowledge of SDTM and ADaM data standards and datasets.
• Experience coordinating with CROs and external vendors.

Responsibilities

• Generate SDTM and ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for regulatory submissions and publications.
• Oversee CRO programmers to ensure timely, compliant deliverables.
• Support clinical study reports, DSURs, and exploratory analyses.
• Adhere to FDA regulations and good clinical practice for submissions.

Skills

SAS programming

R programming

SDTM/ADaM

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team working with a global pharmaceutical client. You will lead programming activities, ensure data quality, and contribute to regulatory submissions.

Responsibilities include generating SDTM/ADaM specs, developing SAS and R programs, overseeing CRO deliverables, and aligning with FDA guidelines for submissions.