Principal Statistical Programmer (Remote) – SAS, R, CDISC

1Es02 Northgatearinso Granada S.L.U.; Granada; Remote; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Cytel Inc. is recruiting a Senior/Principal Statistical Programmer (SAS + R) for remote work, embedded with a pharma client. The role focuses on SDTM/ADaM specifications, complex datasets, and reports for regulatory submissions.

You will lead programming efforts, ensure data quality, and supervise CRO deliverables across multiple studies. The ideal candidate has 7+ years in biotech/pharma biometrics, expert SAS skills, and experience with FDA/ICH guidelines.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interaction with FDA/ICH regulations.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for clinical development programs and oversee CRO deliverables.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.

Kenntnisse

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

R programming

Python

Unix/Linux

Ausbildung

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

git

Jobbeschreibung

Cytel Inc. is recruiting a Senior/Principal Statistical Programmer (SAS + R) for remote work, embedded with a pharma client. The role focuses on SDTM/ADaM specifications, complex datasets, and reports for regulatory submissions.

You will lead programming efforts, ensure data quality, and supervise CRO deliverables across multiple studies. The ideal candidate has 7+ years in biotech/pharma biometrics, expert SAS skills, and experience with FDA/ICH guidelines.