Senior Statistical Programmer (SAS + R) - Remote

Between Group; Burgos; Remote; EUR 85.000 - 135.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a sponsor in the pharmaceutical sector. The role requires delivering SDTM/ADaM datasets and comprehensive program outputs across multiple studies, while guiding CRO programmers and ensuring data quality for regulatory submissions.

The candidate will develop SAS and R code for listings, tables, and graphs, and adhere to FDA guidelines throughout the lifecycle of clinical trials.

Qualifikationen

• Senior/Principal Statistical Programmer with SAS and R expertise.
• Experience with SDTM and ADaM data standards.
• Experience delivering datasets, listings, tables and graphs for clinical trials.
• Knowledge of FDA guidelines and regulatory submissions.

Aufgaben

• 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 programming outputs and maintain SAS/R programs for trials.
• Oversee CRO programming deliverables across studies to ensure timelines.
• Support preparation of clinical study reports and regulatory submissions.

Kenntnisse

Statistical programming

SDTM

ADaM

Clinical data analysis

Regulatory knowledge

CRO oversight

Tables and graphs

FDA regulations

Tools

SAS

R

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a sponsor in the pharmaceutical sector. The role requires delivering SDTM/ADaM datasets and comprehensive program outputs across multiple studies, while guiding CRO programmers and ensuring data quality for regulatory submissions.

The candidate will develop SAS and R code for listings, tables, and graphs, and adhere to FDA guidelines throughout the lifecycle of clinical trials.