Principal Statistical Programmer (SAS + R) – Remote

Durban University of Technology; Pietermaritzburg; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming activities for multiple clinical development programs. You will generate SDTM/ADaM specifications, datasets, and define.xmls, while delivering SAS and R programs and supervising CRO workstreams.

The role requires strong CDISC experience and regulatory submission expertise. You will work independently in a fast-paced environment, coordinating with statisticians and colleagues to ensure high-quality outputs and

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics
• Exceptional SAS programming skills and CDISC standard experience
• Extensive CDISC (SDTM, ADaM, Define.xml) and FDA/ICH regulation familiarity
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead effectively
• Strong communication and leadership abilities

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guides and define.xml files for multiple studies
• Develop SAS programs to produce datasets, listings, tables and graphs
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programmers to ensure quality and timelines
• Support clinical study reports, regulatory submissions, publications and DSURs
• Follow FDA regulations and GCP guidelines for electronic submissions
• Contribute to standards for programming tools, outputs and macros
• Develop CRFs, edit checks, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with CROs, vendors and partners to meet timelines
• Create SOPs and work instructions for programming practices

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulation knowledge

Regulatory submissions

Team leadership

Independent work

R programming

Education

Bachelor's degree in Computer Science, Mathematics, or Statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming activities for multiple clinical development programs. You will generate SDTM/ADaM specifications, datasets, and define.xmls, while delivering SAS and R programs and supervising CRO workstreams.

The role requires strong CDISC experience and regulatory submission expertise. You will work independently in a fast-paced environment, coordinating with statisticians and colleagues to ensure high-quality outputs and