Principal Statistical Programmer - Remote, SAS & R Lead

Staff Solutions; South Africa; Remote; ZAR 1,824,000 - 2,985,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead statistical programming across multiple Clinical Development programs for a sponsor client.

You will generate SDTM/ADaM datasets and define.xml, write SAS and R programs, and oversee CRO deliverables while ensuring high quality and regulatory compliance. The role requires 7+ years of experience, deep CDISC expertise, and strong communication and leadership.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interacting with FDA/regulators.
• Ability to work independently.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality programming results and validate SAS/R programs for clinical studies.
• Oversee CROs' programming deliverables to meet timelines.
• Assist in preparing clinical study reports, regulatory submissions, and DSURs.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review data transfer specifications for external vendors.
• Collaborate with internal and external partners to meet project goals.

Skills

SAS programming

Leadership

Independent work

Communication

Biostatistics knowledge

Education

Bachelor's degree in computer science / data science / statistics

Tools

SAS

R

CDISC SDTM/ADaM

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead statistical programming across multiple Clinical Development programs for a sponsor client.

You will generate SDTM/ADaM datasets and define.xml, write SAS and R programs, and oversee CRO deliverables while ensuring high quality and regulatory compliance. The role requires 7+ years of experience, deep CDISC expertise, and strong communication and leadership.