Principal Statistical Programmer (Remote) - Lead SDTM/ADaM

Apbsa; Cape Town; Remote; ZAR 1,200,000 - 1,800,000; Full time

Job summary

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

You will implement reporting and analysis activities for clinical trials, generate SDTM/ADaM datasets, and oversee CRO programmers to ensure high-quality outputs within timelines. You will work independently with minimal supervision, contribute to clinical study reports, regulatory submissions, and exploratory analyses, and ensure compliance

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics preferred.
• 7+ years as Statistical Programmer in biotech/pharma clinical development biometrics.
• Expert SAS programming skills for clinical development environments.
• Experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs with inferential statistics.
• Deliver high-quality programming results and maintain SAS and/or R programs for clinical programs.
• Oversee CRO statistical programming deliverables to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications, DSURs and exploratory analyses.

Skills

SAS programming

CDISC standards

Regulatory submissions

Leadership

Education

Bachelor's degree in computer science or statistics

Tools

R

Python

Unix/Linux

Git

Shiny

Job description

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

You will implement reporting and analysis activities for clinical trials, generate SDTM/ADaM datasets, and oversee CRO programmers to ensure high-quality outputs within timelines. You will work independently with minimal supervision, contribute to clinical study reports, regulatory submissions, and exploratory analyses, and ensure compliance