Remote Principal Statistical Programmer - SAS & R

Dis-Chem Pharmacies; South Africa; Remote; ZAR 700,000 - 1,200,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely within one of our pharmaceutical client programs.

You will independently manage statistical programming activities, generate SDTM/ADaM datasets, and deliver complex tables and graphics in collaboration with statisticians. You will lead CRO programming deliverables, contribute to regulatory submissions, and ensure compliance with FDA/ICH guidelines.

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 similar
• Exceptional SAS programming skills and expertise in clinical development environments
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA/global authorities

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies
• Develop SAS programs to produce datasets, listings, tables and graphs
• Deliver high-quality SAS/R outputs for clinical programs
• Oversee CRO programming deliverables to meet timelines
• Support regulatory submissions and clinical study reports
• Comply with FDA regulations and electronic submission guidelines
• Contribute to standards for programming tools and documentation
• Develop data transfer specifications for external vendors
• Collaborate with CROs, vendors and partners to meet project goals
• Provide SOPs and work instructions for statistical programming practices

Skills

SAS programming

CDISC (SDTM/ADaM)

Regulatory submissions

Leadership

Independent worker

Communication skills

R

Python

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely within one of our pharmaceutical client programs.

You will independently manage statistical programming activities, generate SDTM/ADaM datasets, and deliver complex tables and graphics in collaboration with statisticians. You will lead CRO programming deliverables, contribute to regulatory submissions, and ensure compliance with FDA/ICH guidelines.