Principal Statistical Programmer (Remote) – SAS + R Lead

SAdocs; South Africa; À distance; ZAR 900 000 - 1 350 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely within a sponsor-dedicated setup. You will deliver SDTM/ADaM specs, datasets, and define.xml for multiple studies, writing SAS and R programs, and overseeing CRO output to ensure high-quality, timely results.

The role requires 7+ years in biostatistics programming, strong CDISC expertise, and experience with regulatory submissions. Independence, leadership, and clear communication are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interaction with FDA/global regulators.
• Must be able to work independently and lead.
• Outstanding communication and leadership skills.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality SAS/R programming outputs tailored to clinical development needs.
• Oversee CRO programmers to meet timelines and quality.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specs for external vendors.
• Collaborate with internal and external partners to meet project goals.
• Review and author SOPs and Work Instructions for programming practices.

Connaissances

SAS programming

R programming

CDISC SDTM

CDISC ADaM

FDA/ICH regulations

Data standards

Leadership

Communication

Formation

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

Outils

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely within a sponsor-dedicated setup. You will deliver SDTM/ADaM specs, datasets, and define.xml for multiple studies, writing SAS and R programs, and overseeing CRO output to ensure high-quality, timely results.

The role requires 7+ years in biostatistics programming, strong CDISC expertise, and experience with regulatory submissions. Independence, leadership, and clear communication are essential.