Senior Statistical Programmer (SAS + R) – Remote

Department Of Education Tasmania; South Africa; Remote; ZAR 1,495,000 - 2,492,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely with a global pharmaceutical client, delivering SAS and R programming for SDTM/ADaM data structures and regulatory submissions.

You will guide programming activities and collaborate with CROs to ensure data quality and timely delivery. The role requires 7+ years of clinical programming experience, strong SAS skills, CDISC standards expertise, and the ability to work independently in a fast-paced environment with FDA/ICH

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in clinical development.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and lead projects.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality results including SAS and/or R programs tailored to clinical programs.
• Oversee CRO programming deliverables to ensure high quality and timelines.
• Support preparation of clinical study reports, submissions, publications, DSUR, analyses.
• Follow FDA regulations and guidelines for regulatory submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external data.
• Collaborate with CROs, vendors and partners to meet timelines.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely with a global pharmaceutical client, delivering SAS and R programming for SDTM/ADaM data structures and regulatory submissions.

You will guide programming activities and collaborate with CROs to ensure data quality and timely delivery. The role requires 7+ years of clinical programming experience, strong SAS skills, CDISC standards expertise, and the ability to work independently in a fast-paced environment with FDA/ICH