Principal Statistical Programmer (SAS + R) — Remote

Manpower España; Salamanca; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor on a global pharmaceutical client. You will lead data analysis, reporting, and regulatory submissions with autonomy while supervising CRO programmers to ensure high-quality results.

You will generate SDTM/ADaM, develop programs for datasets, listings, and tables, and support CSR preparation in line with FDA/GCP guidelines. Collaboration with vendors is essential.

Formación

• Generate SDTM and ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables with descriptive and inferential stats, and graphs.
• Deliver high-quality SAS/R programs tailored to clinical development programs’ needs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of CSRs, regulatory submissions, publications, DSURs, and exploratory analyses.
• Understand and apply FDA regulations and GCP for electronic submissions.

Responsabilidades

• Generate SDTM/ADaM specs, datasets, define.xml and reviewer’s guide.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver SAS/R programs for clinical development programs.
• Oversee CRO programmers and ensure timelines and quality.
• Support CSR, regulatory submissions, and DSUR analyses.
• Ensure FDA/GCP compliance for reporting of trial data.

Conocimientos

SAS

R

SDTM

ADaM

Clinical trials

CRO oversight

Descripción del empleo

Cytel seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor on a global pharmaceutical client. You will lead data analysis, reporting, and regulatory submissions with autonomy while supervising CRO programmers to ensure high-quality results.

You will generate SDTM/ADaM, develop programs for datasets, listings, and tables, and support CSR preparation in line with FDA/GCP guidelines. Collaboration with vendors is essential.