Senior Principal Statistical Programmer (SAS + R) – Remote

Ayanet; Brea de Aragón; À distance; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor dedicated to pharmaceutical development. You will develop SDTM/ADaM datasets, create define.xml and review guides, and deliver complex listings and graphs for multiple studies.

You will oversee CRO programmers, ensure timelines, and contribute to SARs, regulatory submissions, and exploratory analyses in a remote, globally distributed team.

Qualifications

• Experience with SDTM/ADaM specifications and data sets.
• Senior/lead statistical programming in clinical trials.
• Ability to oversee CRO programming deliverables and timelines.

Responsabilités

• Generate SDTM/ADaM specs, define.xml, and reviewer's guide for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for regulatory submissions.
• Oversee CRO programmers to ensure quality and timelines.
• Support clinical study reports, DSURs, and exploratory analyses.
• Ensure compliance with FDA guidance and electronic submission standards.

Connaissances

SAS programming

R programming

SDTM

ADaM

Clinical data analysis

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor dedicated to pharmaceutical development. You will develop SDTM/ADaM datasets, create define.xml and review guides, and deliver complex listings and graphs for multiple studies.

You will oversee CRO programmers, ensure timelines, and contribute to SARs, regulatory submissions, and exploratory analyses in a remote, globally distributed team.