Senior Statistical Programmer SAS + R — Remote

Placements24; Mbombela (Nelspruit); Hybride; ZAR 900 000 - 1 200 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) dedicated to one pharmaceutical client, with Cytel backing. You will lead SAS and R programming for SDTM/ADaM outputs and collaborate with CROs to ensure timely, high-quality data deliverables.

The role requires independent work, 7+ years in Pharma Biostatistics programming, and strong communication and leadership skills for regulatory submissions and data analysis plans.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma/Clinical Biometrics.
• Exceptional SAS programming skills and experience delivering programming procedures.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulations.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses.
• Ensure compliance with FDA guidelines for reporting clinical trial data (GCP, eSubmissions).
• Contribute to standards for programming tools, outputs and macros.
• Help develop CRFs, edit checks and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and partners to meet project goals.

Connaissances

SAS programming

Statistical programming

Leadership

Communication

Formation

Bachelor's in computer science, data science, maths or statistics

Outils

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) dedicated to one pharmaceutical client, with Cytel backing. You will lead SAS and R programming for SDTM/ADaM outputs and collaborate with CROs to ensure timely, high-quality data deliverables.

The role requires independent work, 7+ years in Pharma Biostatistics programming, and strong communication and leadership skills for regulatory submissions and data analysis plans.