Senior Principal Statistical Programmer (SAS & R) - Remote

Veterinary St

Nava

A distancia

EUR 65.000 - 95.000

Jornada completa

Hace 4 días

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Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated role. You will develop SDTM/ADaM specifications, datasets, tables, and graphs for multiple studies, while overseeing CROs and ensuring high-quality outputs.

Knowledge of FDA regulations and GCP is essential. The role reports to the Biostatistics and Programming leadership and involves independent work with minimal supervision across diverse therapeutic areas within clinical development

Formación

Senior statistical programmer with independent work style and minimal supervision.

Responsabilidades

Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml files for multiple studies.
Develop SAS programs to generate datasets, listings, tables, and graphs.
Deliver high-quality statistical programming results with SAS and/or R.
Oversee CROs' statistical programming deliverables across studies and ensure timelines.
Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
Understand and apply FDA regulations affecting clinical trial data reporting (GCP & eSubmissions).
Contribute to standards for programming tools, outputs, and macros.
Develop CRFs, edit check specs, and data validation plans.
Provide review and quality checks of programming outputs.