Senior Statistical Programmer (SAS/R) – Remote Lead

Department Of Education Tasmania; South Africa; À distance; ZAR 900 000 - 1 500 000; Plein temps

Résumé du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharmaceutical client, providing expert programming support across SDTM/ADaM deliverables and regulatory submissions.

You will lead CRO collaborations, develop complex analyses, and ensure high-quality, on-time data outputs in a fully embedded sponsor role. You will design and implement SAS and R programs, maintain standards, and contribute to study reports and regulatory documents, while adhering to

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of statistical programming experience in biotech/pharma.
• Strong SAS programming and CDISC standards expertise.
• Experience with regulatory submissions and FDA/ICH.
• Ability to work independently and lead teams.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, and publications.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external functions to meet timelines and goals.
• Draft SOPs and Work Instructions for statistical programming practices.

Connaissances

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent worker

Leadership & communication

Formation

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Outils

R

Python

Git

Unix/Linux

Description du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a pharmaceutical client, providing expert programming support across SDTM/ADaM deliverables and regulatory submissions.

You will lead CRO collaborations, develop complex analyses, and ensure high-quality, on-time data outputs in a fully embedded sponsor role. You will design and implement SAS and R programs, maintain standards, and contribute to study reports and regulatory documents, while adhering to