Principal Statistical Programmer (Remote) - SAS + R Lead

Placements24; Mbombela (Nelspruit); Remote; ZAR 1,990,000 - 2,487,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a pharmaceutical client.

You will lead programming activities, develop SDTM/ADaM specifications, datasets, and define.xml, and oversee CRO deliverables to ensure high quality on clinical studies. The role requires 7+ years of experience, strong SAS, CDISC standards, and experience with regulatory submissions.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team
• Exceptional SAS programming skills and expertise in statistical programming procedures
• Extensive CDISC standards (SDTM, ADaM, Define.xml) experience
• Experience supporting regulatory submissions and interaction with FDA/global regulators
• Must be able to work independently
• Outstanding communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and Define.xml 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' statistical programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSUR
• Follow FDA regulations and good clinical practice for submissions
• Contribute to standards for programming tools, outputs, and macros
• Develop CRFs, edit checks, and data validation plans
• Provide review or author data transfer specifications for external data
• Collaborate with CROs, vendors, and partners to meet project goals
• Provide review or author SOPs and Work Instructions for statistical programming

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent worker

Communication

Education

Bachelor's degree in computer science/data science/mathematics/statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a pharmaceutical client.

You will lead programming activities, develop SDTM/ADaM specifications, datasets, and define.xml, and oversee CRO deliverables to ensure high quality on clinical studies. The role requires 7+ years of experience, strong SAS, CDISC standards, and experience with regulatory submissions.