Programador Estadístico Principal (SAS/R) – Remoto

Schneider Electric; Santiago de Compostela; Remote; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join our sponsor-dedicated team. You will work on clinical development programs across therapeutic areas, delivering SAS and R analyses and ensuring high-quality data outputs for regulatory submissions.

You will independently manage programming activities, oversee CRO partners, and contribute to study reports and exploratory analyses while adhering to FDA guidelines and good clinical practice.

Qualifikationen

• Extensive experience in statistical programming for clinical trials.
• Experience with SDTM and ADaM specifications.
• Experience overseeing CRO programmers and vendor deliverables.
• Familiarity with FDA guidelines for electronic submissions.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming outputs and maintain SAS and/or R programs.
• Oversee CRO's programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, and exploratory analyses.

Kenntnisse

SAS programming

R programming

SDTM/ADaM

Clinical data analysis

FDA regulatory knowledge

Tools

SAS

R

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join our sponsor-dedicated team. You will work on clinical development programs across therapeutic areas, delivering SAS and R analyses and ensuring high-quality data outputs for regulatory submissions.

You will independently manage programming activities, oversee CRO partners, and contribute to study reports and exploratory analyses while adhering to FDA guidelines and good clinical practice.