Lead Statistical Programmer — SAS + R (Remote)

Placements24; Rustenburg; Remote; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Cytel Inc. in South Africa invites applications for a Senior/Principal Statistical Programmer (SAS + R) working remotely with sponsor-dedicated support.

You will lead programming across SDTM/ADaM, define.xml, and reviewer’s guides, while coordinating CRO output and ensuring high-quality deliverables for regulatory submissions. The role requires 7+ years in pharmaceutical biometrics, expert SAS skills, CDISC proficiency, and strong communication and leadership.

Qualifications

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills and expertise in statistical programming procedures
• Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA or global authorities
• Ability to work independently and lead with strong communication

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer's guides, and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality statistical programming results and maintain SAS and/or R programs
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR analyses
• Follow FDA regulations and good clinical practice for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Participate in CRF development, edit checks, and data validation plans
• Provide review/author data transfer specifications for external vendors
• Collaborate with internal/external partners to meet project goals
• Prepare SOPs and Work Instructions for statistical programming practices

Skills

SAS programming

CDISC standards

Regulatory submissions

Leadership

Communication

Independent work

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

R

Python

Java

Shiny

Git

Unix/Linux

Job description

Cytel Inc. in South Africa invites applications for a Senior/Principal Statistical Programmer (SAS + R) working remotely with sponsor-dedicated support.

You will lead programming across SDTM/ADaM, define.xml, and reviewer’s guides, while coordinating CRO output and ensuring high-quality deliverables for regulatory submissions. The role requires 7+ years in pharmaceutical biometrics, expert SAS skills, CDISC proficiency, and strong communication and leadership.