Principal Statistical Programmer — SAS + R (Remote)

Placements24; South Africa; Remote; ZAR 900.000 - 1.800.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead complex programming for global clinical trials. You will develop SDTM/ADaM specifications, datasets, and define.xml, and deliver SAS and R programs for listings, tables and graphs.

In this role you will oversee CRO programmers, ensure regulatory submissions are supported, and contribute to standards for programming tools and documentation while working with minimal supervision.

Qualifikationen

• Bachelor's degree in CS/Data Science/Math/Statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development.
• Excellent SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml experience and regulatory familiarity.
• Experience with regulatory submissions and FDA/ICH interactions.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership.

Aufgaben

• Generate SDTM, ADaM specs and define.xml for multiple studies.
• Develop SAS programs to produce datasets, tables, listings and graphs.
• Deliver high-quality SAS/R code for clinical data analysis.
• Oversee CRO's programming deliverables across studies to meet timelines.
• Support study reports, regulatory submissions, DSURs and exploratory analyses.
• Help follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Assist in CRF edits and data validation plans.

Kenntnisse

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions

Independent work

Leadership

Communication skills

R

Python

Unix/Linux

Git

Ausbildung

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

Tools

SAS

R

Python

Unix/Linux

Git

Shiny

Markdown

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead complex programming for global clinical trials. You will develop SDTM/ADaM specifications, datasets, and define.xml, and deliver SAS and R programs for listings, tables and graphs.

In this role you will oversee CRO programmers, ensure regulatory submissions are supported, and contribute to standards for programming tools and documentation while working with minimal supervision.