Senior Principal Statistical Programmer (Remote)

Placements24; KwaZulu-Natal; Remote; ZAR 1,990,000 - 2,487,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to implement all reporting and analysis activities for Sponsor trials.

The role focuses on delivering SDTM/ADaM specifications, datasets, and complex outputs, while collaborating with CROs and internal teams to ensure timely, high-quality deliverables. The ideal candidate brings 7+ years in statistical programming, strong SAS and CDISC expertise, and experience with regulatory submissions.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred).
• 7+ years as a Statistical Programmer in Biotech/Pharma or similar.
• Exceptional SAS programming skills for clinical development.
• CDISC SDTM/ADaM, Define.xml, medical terminology, FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead effectively.
• Strong written and verbal communication skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and complex graphs.
• Deliver high-quality SAS and/or R programs for clinical development needs.
• Oversee CRO programmers to meet timelines with quality output.
• Support preparation of regulatory submissions, CSR, DSUR, analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs and vendors to meet project goals.
• Draft SOPs and work instructions for statistical programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulation

R

Python

Unix/Linux

Git

Shiny

Markdown

Education

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

Tools

Unix/Linux

Git

Shiny

Markdown

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to implement all reporting and analysis activities for Sponsor trials.

The role focuses on delivering SDTM/ADaM specifications, datasets, and complex outputs, while collaborating with CROs and internal teams to ensure timely, high-quality deliverables. The ideal candidate brings 7+ years in statistical programming, strong SAS and CDISC expertise, and experience with regulatory submissions.