Senior Principal Statistical Programmer - Remote (SAS + R)

Placements24; Mbombela (Nelspruit); Remote; ZAR 1,990,000 - 2,985,000; Full time

Job summary

Placements24 is seeking a Senior/Principal Statistical Programmer with SAS and R expertise to work remotely on pharmaceutical client projects. The role involves independent work on clinical development programs, overseeing CROs, and delivering high-quality data analyses and reporting in compliance with FDA guidelines.

The candidate will develop SDTM/ADaM specifications, create complex tables and graphs, and support regulatory submissions and publications.

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 with CDISC standards.
• Experience supporting regulatory submissions with FDA/ICH guidelines.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming outputs and validate SAS and R programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions, publications, and exploratory analyses.
• Ensure compliance with FDA regulations and good clinical practice.

Skills

SAS programming

CDISC standards (SDTM/ADaM)

Regulatory submissions

Clinical development

Leadership

R programming

Data analysis

Education

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

Tools

SAS

R

Unix/Linux

git

Job description

Placements24 is seeking a Senior/Principal Statistical Programmer with SAS and R expertise to work remotely on pharmaceutical client projects. The role involves independent work on clinical development programs, overseeing CROs, and delivering high-quality data analyses and reporting in compliance with FDA guidelines.

The candidate will develop SDTM/ADaM specifications, create complex tables and graphs, and support regulatory submissions and publications.