Senior Statistical Programmer (SAS & R) – Remote

Recurrent Energy; Sevilla; Remoto; EUR 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a global pharmaceutical client. You will implement reporting and analysis activities, lead SDTM/ADaM development, and oversee CRO programming to ensure high-quality deliverables.

You will contribute to regulatory submissions, CSRs, and publications while applying FDA regulations and good clinical practice. Strong SAS/R skills and extensive biotech/pharma experience are essential.

Competenze

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills with expertise in SDTM/ADaM specifications.
• Bachelor's degree in computer science, data science, mathematics, or statistics.

Mansioni

• Develop SAS programs to generate datasets, listings, tables, and graphs for clinical studies.
• Create and maintain SDTM/ADaM specifications, define.xml, and reviewer’s guides.
• Review CRO deliverables to ensure quality and timelines across studies.
• Support clinical study reports, regulatory submissions, and exploratory analyses.
• Adhere to FDA regulations, GCP, and electronic submission guidelines.

Conoscenze

SAS programming

R programming

Statistical programming

FDA regulations knowledge

CRO oversight

Formazione

Bachelor's degree in Computer Science or Statistics

Strumenti

SAS

R

CDISC SDTM/ADaM

Descrizione del lavoro

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a global pharmaceutical client. You will implement reporting and analysis activities, lead SDTM/ADaM development, and oversee CRO programming to ensure high-quality deliverables.

You will contribute to regulatory submissions, CSRs, and publications while applying FDA regulations and good clinical practice. Strong SAS/R skills and extensive biotech/pharma experience are essential.