Principal Statistical Programmer (SAS + R) — Remote

Aspen Pharma Group; Gauteng; Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Aspen Pharma Group in South Africa seeks a Senior/Principal Statistical Programmer (Remote) to lead programming for multiple clinical programs, applying SAS and R to create analysis datasets, listings, tables, and graphs.

You will develop SDTM/ADaM specifications, reviewer's guides, and define.xml, supervise CRO programmers, ensure quality and timeliness, and support regulatory submissions and study reports in line with FDA guidelines.

Qualifications

• Experience delivering SDTM/ADaM datasets and QA documents.
• Proven ability to lead programming deliverables in CRO settings.
• Strong understanding of regulatory requirements for clinical data submissions.

Responsibilities

• Develop SAS programs to generate datasets, listings, tables and graphs.
• Create SDTM/ADaM specifications and define.xml.
• Oversee CRO programming deliverables and ensure timelines.
• Support regulatory submissions and study reports.
• Ensure compliance with FDA/ICH guidelines for electronic submissions.

Skills

SAS

R

Statistical programming

Clinical trials

Tools

SDTM

ADaM

Job description

Aspen Pharma Group in South Africa seeks a Senior/Principal Statistical Programmer (Remote) to lead programming for multiple clinical programs, applying SAS and R to create analysis datasets, listings, tables, and graphs.

You will develop SDTM/ADaM specifications, reviewer's guides, and define.xml, supervise CRO programmers, ensure quality and timeliness, and support regulatory submissions and study reports in line with FDA guidelines.