Senior Principal Statistical Programmer (SAS/R) – Remote

Anthesis Group; Santander; Remote; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer to be dedicated to a sponsor and embedded within a pharmaceutical client, with Cytel backing you. This remote role focuses on delivering high-quality programming for clinical trials, driving SDTM/ADaM workstreams, and ensuring regulatory-compliant outputs across studies.

You will develop SAS and R programs, oversee CRO deliverables, and contribute to reports, submissions, and exploratory analyses under FDA guidelines, maintaining

Qualifikationen

• Senior/Principal Statistical Programmer role in clinical development.
• Experience with SDTM/ADaM is preferred.
• Knowledge of FDA regulations for electronic submissions is expected.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and graphs
• Deliver high-quality SAS and/or R programs tailored to clinical development programs' needs
• Oversee CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions to ensure meeting project timelines and goals
• Provide review and

Kenntnisse

Statistical programming

Clinical development experience

Tools

SAS

R

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer to be dedicated to a sponsor and embedded within a pharmaceutical client, with Cytel backing you. This remote role focuses on delivering high-quality programming for clinical trials, driving SDTM/ADaM workstreams, and ensuring regulatory-compliant outputs across studies.

You will develop SAS and R programs, oversee CRO deliverables, and contribute to reports, submissions, and exploratory analyses under FDA guidelines, maintaining