Senior Principal Statistical Programmer (Remote) - SAS + R

Placements24; South Africa; À distance; ZAR 900 000 - 1 500 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming for multiple clinical development programs. You will implement SDTM/ADaM workflows, develop SAS and R programs, and oversee CRO deliverables with tight timelines.

You will contribute to regulatory submissions and reports, ensuring adherence to FDA/ICH guidelines while collaborating with statisticians and data managers across studies.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years' experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulation.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently and show leadership; strong communication.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and Define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and validate SAS/R programs.
• Oversee CRO programming deliverables and ensure timelines are met.
• Support clinical study reports, regulatory submissions, DSURs, and analyses.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs and vendors to meet project goals.

Connaissances

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Leadership

Communication

Formation

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

Outils

Python

Shiny

Unix/Linux

Git

Markdown

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead programming for multiple clinical development programs. You will implement SDTM/ADaM workflows, develop SAS and R programs, and oversee CRO deliverables with tight timelines.

You will contribute to regulatory submissions and reports, ensuring adherence to FDA/ICH guidelines while collaborating with statisticians and data managers across studies.