Principal Statistical Programmer (SAS & R) – Remote

Plexus Tech; Islas Baleares; A distancia; EUR 85.000 - 125.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated program, embedded with one of our global pharmaceutical clients. The role emphasizes independent work, high-quality programming deliverables, and collaboration with CROs and internal teams to support regulatory submissions and exploratory analyses.

The successful candidate will develop SDTM/ADaM datasets, complex listings and graphs, and ensure compliance with FDA guidelines and GCP in

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions
• 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 (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and

Conocimientos

SAS

R programming

Clinical trial programming

SDTM/ADaM

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a sponsor-dedicated program, embedded with one of our global pharmaceutical clients. The role emphasizes independent work, high-quality programming deliverables, and collaboration with CROs and internal teams to support regulatory submissions and exploratory analyses.

The successful candidate will develop SDTM/ADaM datasets, complex listings and graphs, and ensure compliance with FDA guidelines and GCP in