Remote Principal Statistical Programmer (SAS + R)

Dante; South Africa; Remote; ZAR 1,000,000 - 1,600,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on major pharmaceutical programs. You will implement reporting and analysis activities, lead SAS and R programming efforts, and oversee CRO programmers to ensure timely, high-quality data deliverables.

Responsibilities include SDTM/ADaM development, defining specifications, and contributing to regulatory documents while adhering to FDA/ICH guidance. Strong leadership and independent work are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma/biometrics.
• Exceptional SAS programming skills and CDISC standards expertise.
• Experience with regulatory submissions and FDA/ICH guidelines.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer's guides and define.xml.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality programming for clinical development programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions and analyses.
• Conform to FDA regulations and electronic submission guidelines.
• Contribute to standards for programming tools, outputs and macros.
• Assist in CRF development, edit checks, and data validation plans.

Skills

Independence

Communication skills

Leadership

Biostatistics knowledge

Education

Bachelor's degree in computer science or statistics

Tools

SAS

R

Define.xml

CDISC SDTM/ADaM

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on major pharmaceutical programs. You will implement reporting and analysis activities, lead SAS and R programming efforts, and oversee CRO programmers to ensure timely, high-quality data deliverables.

Responsibilities include SDTM/ADaM development, defining specifications, and contributing to regulatory documents while adhering to FDA/ICH guidance. Strong leadership and independent work are essential.