Remote Principal Statistical Programmer SAS and R

Placements24; South Africa; Remote; ZAR 900,000 - 1,100,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely for a sponsor, embedded with a global pharmaceutical client. You will implement reporting and analysis activities across trials with autonomy and leadership in a dynamic team.

Role emphasizes SAS/R programming, CDISC standards, and regulatory submissions. You will collaborate with CROs and internal teams, contribute to standards, and support SCR/DSUR tasks while adhering to FDA guidelines and quality practices.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (required).
• 7+ years as Statistical Programmer in Biotech/Pharma biometrics or similar team.
• Exceptional SAS programming skills for clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory submissions.
• Ability to work independently and supervise CRO programmers when needed.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R programs for clinical development needs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Ensure compliance with FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks and data validation plans.
• Review and author data transfer specifications for external vendors.
• Collaborate with CROs, vendors and partners to meet project goals.
• Review and author SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Clinical data analysis

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely for a sponsor, embedded with a global pharmaceutical client. You will implement reporting and analysis activities across trials with autonomy and leadership in a dynamic team.

Role emphasizes SAS/R programming, CDISC standards, and regulatory submissions. You will collaborate with CROs and internal teams, contribute to standards, and support SCR/DSUR tasks while adhering to FDA guidelines and quality practices.