Principal Statistical Programmer - Remote

Placements24; South Africa; Remote; ZAR 1,400,000 - 2,100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for remote work in South Africa. You will be dedicated to clinical development programs and oversee CRO programmers to ensure high-quality data deliverables.

Responsibilities include creating SDTM/ADaM specs, SAS and R programs, and contributing to regulatory submissions and study reports. Strong independence, leadership, and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma or similar.
• Strong SAS programming skills and SDTM/ADaM experience.
• Experience with regulatory submissions and FDA/ICH guidelines.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables and graphs
• Deliver high-quality SAS and R programs for clinical development needs
• Oversee CROs' programming deliverables to meet timelines
• Support creation of CSRs, regulatory submissions, publications and DSUR
• Follow FDA regulations and ICH guidelines for electronic submissions
• Develop and maintain standards for programming tools and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide data transfer specifications for external vendor data
• Collaborate with internal/external partners to meet timelines
• Review SOPs and Work Instructions for statistical programming

Skills

SAS programming

R programming

CDISC standards

Clinical data

Leadership

Education

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

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for remote work in South Africa. You will be dedicated to clinical development programs and oversee CRO programmers to ensure high-quality data deliverables.

Responsibilities include creating SDTM/ADaM specs, SAS and R programs, and contributing to regulatory submissions and study reports. Strong independence, leadership, and regulatory knowledge are essential.