Remote Principal Statistical Programmer (SAS + R)

Hipoges Iberia; España; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor, embedded within a pharmaceutical client. You will lead programming tasks across studies, ensure data quality, and support regulatory submissions while guiding CRO work to high standards.

The role emphasizes independent work, adherence to FDA guidelines, and the development of reusable programming standards for future trials.

Formación

• Extensive experience as Principal Statistical Programmer in clinical development.
• Proven ability to deliver SDTM/ADaM specifications and datasets for multiple studies.
• Knowledge of FDA regulations, GCP, and electronic submissions guidance.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guides, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CROs' statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Comply with FDA regulations affecting reporting of trial data and electronic submissions.
• Contribute to creating and maintaining standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet project timelines.

Conocimientos

SAS

R

SDTM

ADaM

Clinical trial programming

CRO oversight

Regulatory submissions

Data analysis

Herramientas

SAS software

R

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor, embedded within a pharmaceutical client. You will lead programming tasks across studies, ensure data quality, and support regulatory submissions while guiding CRO work to high standards.

The role emphasizes independent work, adherence to FDA guidelines, and the development of reusable programming standards for future trials.