Senior Principal Statistical Programmer (SAS + R) – Remote

Imizizi; Pretoria; Remote; ZAR 1,830,000 - 2,829,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within a global pharmaceutical client.

You will lead SAS and R programming, SDTM/ADaM deliverables, and oversight of CROs to ensure timely, high-quality outputs. Responsibilities include developing datasets, listings, tables, and graphs; ensuring regulatory submission readiness; contributing to standards; and collaborating across functional teams while maintaining independence and strong

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or related
• Exceptional SAS programming skills for clinical development
• CDISC SDTM/ADaM/Define.xml and regulatory submission experience
• Experience interacting with regulatory authorities (FDA/global)
• Ability to work independently and lead
• Strong written and verbal communication and leadership skills

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer's guides and define.xml for multiple studies
• Develop SAS programs to produce datasets, complex listings, tables and graphs
• Deliver high-quality statistical outputs using SAS and/or R
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of CSRs, regulatory submissions, publications, DSURs and exploratory analyses
• Follow FDA/ICH regulations and GCP for electronic submissions
• Create and maintain standards for programming tools, outputs, and macros
• Contribute to CRF development, edit checks, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with CROs, vendors, and partners to meet project goals
• Draft SOPs/work instructions for programming practices

Skills

SAS programming

R programming

CDISC standards

Statistical programming

Education

Bachelor's degree in Computer Science/Data Science/Statistics

Tools

SAS

R

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within a global pharmaceutical client.

You will lead SAS and R programming, SDTM/ADaM deliverables, and oversight of CROs to ensure timely, high-quality outputs. Responsibilities include developing datasets, listings, tables, and graphs; ensuring regulatory submission readiness; contributing to standards; and collaborating across functional teams while maintaining independence and strong