Remote Principal Statistical Programmer (SAS + R)

Old Mutual Limited; Klerksdorp; Remote; ZAR 1,997,000 - 2,995,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to lead the programming deliverables for global clinical studies. You will independently develop SAS and R programs, create SDTM/ADaM datasets, and define.xml documents while ensuring regulatory compliance and quality across CRO work.

Collaboration with statisticians, vendors, and clinical partners is essential. You will guide reporting, tables, listings, listings across trials, and contribute to study reports and

Qualifications

• Minimum bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC SDTM, ADaM, and Define.xml
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead
• Strong written and verbal communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality SAS/R programs tailored to clinical development programs
• 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 good clinical practice for electronic 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 vendor data
• Collaborate with CROs and vendors to meet project milestones
• Prepare SOPs and Work Instructions for statistical programming practices

Skills

SAS programming

R

CDISC SDTM/ADaM/Define.xml

FDA/ICH regulation

independence/ownership

communication/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. is seeking a Senior/Principal Statistical Programmer (Remote) to lead the programming deliverables for global clinical studies. You will independently develop SAS and R programs, create SDTM/ADaM datasets, and define.xml documents while ensuring regulatory compliance and quality across CRO work.

Collaboration with statisticians, vendors, and clinical partners is essential. You will guide reporting, tables, listings, listings across trials, and contribute to study reports and