Principal Statistical Programmer (SAS + R) – Remote

Medical Resources Group; Rustenburg; Remote; ZAR 1,983,000 - 2,974,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer who will be embedded with a pharmaceutical client, delivering high-quality programming for SDTM/ADaM datasets and reports. You will manage CRO data deliverables, ensure regulatory readiness, and contribute to standardization of programming practices.

You will lead complex programming tasks, work independently with minimal supervision, and collaborate across teams to drive timely, accurate analysis and impactful study reports in a fully

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of clinical statistics programming experience.
• Expert SAS programming in a clinical development environment.
• CDISC SDTM/ADaM and Define.xml experience.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and demonstrate leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs generating datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and R programs tailored to clinical development needs.
• Oversee CROs’ programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GCP 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 internal/external partners to meet project goals.
• Draft SOPs and Work Instructions for programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA regulatory submissions

Independent work

Leadership

Education

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

Tools

Define.xml

SAS

R

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer who will be embedded with a pharmaceutical client, delivering high-quality programming for SDTM/ADaM datasets and reports. You will manage CRO data deliverables, ensure regulatory readiness, and contribute to standardization of programming practices.

You will lead complex programming tasks, work independently with minimal supervision, and collaborate across teams to drive timely, accurate analysis and impactful study reports in a fully