Senior Statistical Programmer (SAS + R) - Remote

Hoteljobs; Stellenbosch; Remote; ZAR 1,985,000 - 2,812,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs for a global pharma client, with Cytel providing backing and governance. You will operate with autonomy, managing complex programming tasks and CRO oversight.

Responsibilities include generating SDTM and ADaM specifications, creating datasets, listings, tables and graphs, supporting regulatory submissions, and ensuring adherence to FDA/ICH guidelines.

Qualifications

• : Minimum bachelor’s degree in computer science, data science, mathematics or statistics preferable.
• :

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and complex graphs
• Deliver high-quality statistical programming results with SAS and/or R
• Oversee CROs' statistical programming deliverables across studies to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Assist in CRF development, edit checks, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external partners to meet project goals
• Contribute to SOPs/Work Instructions related to programming practices

Skills

SAS programming

CDISC SDTM

ADaM

FDA/ICH regulation

Regulatory submissions

Independent worker

Leadership

Education

Bachelor's degree in Computer Science, Data Science, Mathematics or Statistics

Tools

R

Python

Git

Unix/Linux

Shiny

Markdown

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs for a global pharma client, with Cytel providing backing and governance. You will operate with autonomy, managing complex programming tasks and CRO oversight.

Responsibilities include generating SDTM and ADaM specifications, creating datasets, listings, tables and graphs, supporting regulatory submissions, and ensuring adherence to FDA/ICH guidelines.