Principal Statistical Programmer (SAS + R) – Remote

Ue Candidate Experience Eña; Valladolid; Remote; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Cytel, sponsor-dedicated, seeks a Senior/Principal Statistical Programmer (Remote) to work with a global pharmaceutical client, delivering autonomous, high-quality programming for clinical trials.

You will implement reporting and analysis activities, oversee CRO programmers, generate SDTM/ADaM specifications, and support regulatory submissions while ensuring FDA guidelines are followed.

Qualifikationen

• Extensive experience in clinical statistical programming using SAS.
• Experience with SDTM/ADaM data structures and specifications.
• Experience supervising CRO programmers and ensuring high-quality deliverables.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.Xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables and complex graphs with statistics.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CROs' programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and publications.
• Ensure compliance with FDA regulations and guidelines for electronic submissions.
• Contribute to standardization and validation of programming tools, outputs, and macros.
• Collaborate with internal and external partners to meet project goals.

Kenntnisse

Statistical programming

SAS

R

Tools

SAS

R

Jobbeschreibung

Cytel, sponsor-dedicated, seeks a Senior/Principal Statistical Programmer (Remote) to work with a global pharmaceutical client, delivering autonomous, high-quality programming for clinical trials.

You will implement reporting and analysis activities, oversee CRO programmers, generate SDTM/ADaM specifications, and support regulatory submissions while ensuring FDA guidelines are followed.