Principal Statistical Programmer (SAS & R) - Remote

Ethos; Santa Cruz de Tenerife; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Cytel is recruiting a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within one of our pharmaceutical clients. The role involves leveraging SAS and R to deliver SDTM/ADaM datasets, tables, and listings while ensuring regulatory compliance.

The ideal candidate will oversee CRO programming activities, develop and validate reports, and contribute to regulatory submissions, with a strong emphasis on FDA guidelines and GCP.

Qualifikationen

• Extensive experience in statistical programming for clinical trials.
• Proven ability to oversee CRO programming deliverables.
• Strong knowledge of FDA guidelines and ICH GCP.
• Experience with SDTM/ADaM specifications.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results using SAS and R.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA regulations for reporting clinical trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal and external partners to meet project goals.

Kenntnisse

SAS programming

R programming

SDTM/ADaM

CRO oversight

Regulatory submissions

Tools

SAS

R

Jobbeschreibung

Cytel is recruiting a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within one of our pharmaceutical clients. The role involves leveraging SAS and R to deliver SDTM/ADaM datasets, tables, and listings while ensuring regulatory compliance.

The ideal candidate will oversee CRO programming activities, develop and validate reports, and contribute to regulatory submissions, with a strong emphasis on FDA guidelines and GCP.