Principal Statistical Programmer: SAS + R (Remote)

Sibanye Stillwater

South Africa

À distance

ZAR 1 200 000 - 2 000 000

Plein temps

Il y a 7 jours
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Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join a sponsor-dedicated, fully remote role embedded with a global pharmaceutical client.

You will work under the Director, Biostatistics and Programming, delivering high-quality programming for SDTM/ADaM datasets, listings, and reports while ensuring regulatory compliance. The position requires 7+ years of experience, extensive CDISC experience, and the ability to oversee CRO programmers.

Qualifications

  • At a minimum bachelor's degree in computer science, data science, mathematics, or statistics.
  • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
  • Exceptional SAS programming skills and expertise in development and implementation of statistical programming procedures.
  • Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
  • Experience supporting regulatory submissions and interactions with FDA or global authorities.
  • Must be able to work independently and communicate effectively.
  • Leadership experience is advantageous.

Responsabilités

  • Generate SDTM/ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
  • Develop SAS programs to create datasets, tables, listings, and graphs for clinical reports.
  • Deliver high-quality programming outputs; validate and maintain SAS and/or R programs.
  • Oversee CRO programmers to ensure timely, high-quality deliverables.
  • Contribute to clinical study reports, regulatory submissions, publications, and analyses.
  • Collaborate with CROs, vendors, and internal teams to meet project goals.
  • Document programming standards, SOPs, and data transfer specifications.

Connaissances

SAS programming
Statistical programming
CDISC SDTM/ADaM
FDA/ICH regulation
Leadership
Independent work

Formation

Bachelor's degree in CS/DS/Math/Stats

Outils

R
Python
Java
Shiny
Unix/Linux
git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join a sponsor-dedicated, fully remote role embedded with a global pharmaceutical client.

You will work under the Director, Biostatistics and Programming, delivering high-quality programming for SDTM/ADaM datasets, listings, and reports while ensuring regulatory compliance. The position requires 7+ years of experience, extensive CDISC experience, and the ability to oversee CRO programmers.

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