Remote Principal Statistical Programmer (SAS/R) — Clinical Data Lead

Babylonstoren; Stellenbosch; Remote; ZAR 1,985,000 - 2,977,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join dedicated to a pharmaceutical client within our FSP Services. The role combines SAS and R programming with SDTM/ADaM deliverables and CRO oversight.

You will work independently on complex datasets, develop programs for analyses, and support regulatory submissions in alignment with FDA/ICH guidelines. Strong communication and leadership are essential.

Qualifications

• Bachelor-level degree in a quantitative field or equivalent.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma.
• Strong SAS programming expertise and SDTM/ADaM experience.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide, and Define.xml.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAP/R outputs tailored to clinical programs.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support creation of clinical study reports, regulatory submissions, publications and DSUR.
• Follow FDA/ICH guidance and good clinical practice for electronic submissions.
• Contribute to standardization of programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendors.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs and Work Instructions for programming practices.

Skills

SAS programming

R programming

CDISC standards

Statistical programming

FDA/ICH regulations

Education

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

Tools

SAS

R

Python

Git

Unix/Linux

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join dedicated to a pharmaceutical client within our FSP Services. The role combines SAS and R programming with SDTM/ADaM deliverables and CRO oversight.

You will work independently on complex datasets, develop programs for analyses, and support regulatory submissions in alignment with FDA/ICH guidelines. Strong communication and leadership are essential.