Remote Principal Statistical Programmer (SAS/R)

Helderberg Personnel Cc; Wes-Kaap; Remote; ZAR 1,000,000 - 1,400,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R for a remote role embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM specifications, deliver complex listings and graphs, and oversee CRO deliverables to ensure timely, high-quality results.

You will work independently with minimal supervision, contribute to regulatory submissions and study reports, and apply CDISC standards in a dynamic biostatistics environment, with opportunities for

Qualifications

• Must have 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.

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 graphs
• Deliver high-quality statistical programming results and maintaining SAS and/or R programs
• Oversee CRO's statistical programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and analyses
• Understand and follow FDA regulations for reporting clinical trial data
• 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 vendor data
• Collaborate with internal/external functions to meet timelines
• Provide review/author SOPs and Work Instructions related to statistical programming practices

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication skills

CRO oversight

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R for a remote role embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM specifications, deliver complex listings and graphs, and oversee CRO deliverables to ensure timely, high-quality results.

You will work independently with minimal supervision, contribute to regulatory submissions and study reports, and apply CDISC standards in a dynamic biostatistics environment, with opportunities for