Remote Senior Statistical Programmer – SAS & R

Anonymous; Cape Town; Remote; ZAR 1,976,000 - 2,964,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote, sponsor-dedicated role embedded with a pharmaceutical client.

You will deliver SDTM/ADaM specifications, datasets, and complex analyses while guiding CRO programming deliverables and ensuring regulatory readiness. The role requires 7+ years in biotech/pharma programming, independent work, and the ability to drive high-quality outputs.

Qualifications

• 7+ years as a Statistical Programmer in biotech/pharma Clinical Development Biometrics
• Exceptional SAS programming skills and SDTM/ADaM/Define.xml experience
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead CRO programming deliverables
• Strong communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and graphs
• Deliver high-quality statistical programming results using SAS and/or R
• Oversee CROs' scripting deliverables to meet timelines and quality standards
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses
• 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 specification reviews for external data
• Collaborate with CROs, vendors, and partners to meet goals
• Create SOPs and Work Instructions for programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Data analysis

Leadership

Communication

Education

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

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote, sponsor-dedicated role embedded with a pharmaceutical client.

You will deliver SDTM/ADaM specifications, datasets, and complex analyses while guiding CRO programming deliverables and ensuring regulatory readiness. The role requires 7+ years in biotech/pharma programming, independent work, and the ability to drive high-quality outputs.