Principal Statistical Programmer (SAS + R) – Remote

Ue - Candidate Experience - España; Sevilla; A distancia; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team embedded with a global pharmaceutical client. You will lead programming for clinical development programs and oversee CROs, delivering high-quality data outputs with autonomy.

As part of the FSP Services, you will generate SDTM/ADaM specs, develop SAS and R programs, support regulatory submissions, and ensure compliance with GCP and FDA guidelines.

Formación

• Senior statistical programmer with extensive experience in clinical trials.
• Experience delivering SDTM/ADaM specifications and define.xmls.
• Ability to oversee CRO programmers and ensure data quality.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for studies.
• Develop SAS programs to generate datasets, tables, listings, and graphs.
• Deliver high-quality SAS/R outputs for clinical programs and interact with statisticians.
• Oversee CRO deliverables to meet timelines and quality standards.
• Support preparation of CRFs, data validation plans, and regulatory submissions.
• Follow FDA regulations and GCP for reporting and submissions.
• Contribute to programming standards, validation, and documentation.

Conocimientos

SAS programming

R programming

SDTM/ADaM knowledge

Herramientas

SAS

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated team embedded with a global pharmaceutical client. You will lead programming for clinical development programs and oversee CROs, delivering high-quality data outputs with autonomy.

As part of the FSP Services, you will generate SDTM/ADaM specs, develop SAS and R programs, support regulatory submissions, and ensure compliance with GCP and FDA guidelines.