Principal Statistical Programmer (SAS + R) Remote

IdealMedic; Vitoria; À distance; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated role embedded with a pharmaceutical client. You will contribute to SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO deliverables for multiple studies.

You will ensure data quality, support study reports and regulatory submissions, and align with FDA guidelines. This role emphasizes autonomy and high-level technical expertise in clinical programming.

Qualifications

• Proven experience in SAS programming for clinical trials.
• Knowledge of R programming.
• Understanding of FDA regulations and eCTD submissions.

Responsabilités

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs for clinical trials.
• Deliver high-quality statistical programming results including validation and maintenance of SAS and R programs.
• Oversee CRO programmers to ensure timely and high-quality data deliverables.
• Assist in preparation of clinical study reports, regulatory submissions and exploratory analyses.
• Collaborate with internal and external partners to meet project timelines.

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated role embedded with a pharmaceutical client. You will contribute to SDTM/ADaM specifications, develop SAS and R programs, and oversee CRO deliverables for multiple studies.

You will ensure data quality, support study reports and regulatory submissions, and align with FDA guidelines. This role emphasizes autonomy and high-level technical expertise in clinical programming.