Principal Statistical Programmer (Remote) – SAS & R Expert

Placements24; Upington; Remote; ZAR 1.495.000 - 2.160.000; Vollzeit

Zusammenfassung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work fully remote, embedded with a pharmaceutical client. You will develop SDTM/ADaM datasets, define.xml, reviewer’s guides, and complex analyses, delivering high-quality outputs for regulatory submissions.

The role requires 7+ years in biostatistics programming, strong SAS and CDISC expertise, and ability to lead CROs while ensuring FDA/ICH compliance and timely delivery.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills with CDISC standards and FDA/ICH regulation knowledge.

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 programming results and maintain SAS/R programs for clinical programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR.

Kenntnisse

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulation

Leadership

Communication

CRO oversight

GxP

Ausbildung

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

Unix/Linux

Git

Python

Shiny

Java

Jobbeschreibung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work fully remote, embedded with a pharmaceutical client. You will develop SDTM/ADaM datasets, define.xml, reviewer’s guides, and complex analyses, delivering high-quality outputs for regulatory submissions.

The role requires 7+ years in biostatistics programming, strong SAS and CDISC expertise, and ability to lead CROs while ensuring FDA/ICH compliance and timely delivery.