Principal Statistical Programmer (SAS + R) – Remote

Neural Mentalia; Jaén; Remote; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis for one of our pharmaceutical clients. You will lead programming across SDTM/ADaM, develop SAS and R programs, and oversee CRO deliverables with autonomy.

The successful candidate will manage datasets, tables, and graphs for multiple studies, support regulatory submissions, and ensure compliance with FDA guidance and GCP.

Qualifikationen

• Proficiency in SAS programming for clinical data and table outputs.
• Experience with R for statistical analysis and data visualization.
• Knowledge of SDTM/ADaM standards and CDISC guidelines.

Aufgaben

• Generate SDTM/ADaM specifications, datasets, and define.xml for studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Oversee CRO programming deliverables and ensure timelines and quality.
• Support preparation of CSRs, regulatory submissions, DSURs, and exploratory analyses.
• Adhere to FDA regulations, GCP, and electronic submission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Assist in CRF development, edit checks, and data validation plans.
• Provide expert review of programming outputs.

Kenntnisse

SAS

R

SDTM

ADaM

GCP

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis for one of our pharmaceutical clients. You will lead programming across SDTM/ADaM, develop SAS and R programs, and oversee CRO deliverables with autonomy.

The successful candidate will manage datasets, tables, and graphs for multiple studies, support regulatory submissions, and ensure compliance with FDA guidance and GCP.