Principal Statistical Programmer (SAS + R) - Remote

nationalcaregroup.com; South Africa; Remote; ZAR 900,000 - 1,500,000; 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 work with the Director of Biostatistics and Programming to deliver SDTM/ADaM specifications, datasets, and define.xml, while leading CRO programming deliverables and regulatory submissions. The ideal candidate has 7+ years in statistical programming, expertise in CDISC (SDTM/ADaM/Define.xml), and strong communication and leadership skills.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills and exposure to clinical development environments.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and validate SAS/R programs for clinical programs.
• Oversee CRO programmers to ensure timelines and quality.
• Support preparation of Clinical Study Reports, regulatory submissions and publications.
• 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 internal and external partners to meet project goals.
• Create SOPs and work instructions related to statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication skills

Education

Bachelor's degree in CS/Math/Stats

Tools

SAS

R

Python

Git

Unix/Linux

Job description

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

You will work with the Director of Biostatistics and Programming to deliver SDTM/ADaM specifications, datasets, and define.xml, while leading CRO programming deliverables and regulatory submissions. The ideal candidate has 7+ years in statistical programming, expertise in CDISC (SDTM/ADaM/Define.xml), and strong communication and leadership skills.