Principal Statistical Programmer (SAS + R) – Remote

Multiform Human Development Pty; Klerksdorp; Remote; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Remote work

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role dedicated to a pharmaceutical client. You will lead programming for SDTM/ADaM, develop complex datasets and reports, and ensure regulatory submissions meet FDA/ICH guidelines.

Independent worker with CRO oversight and strong communication is essential. Required 7+ years in biostatistics programming, expertise in CDISC standards, and a degree in a relevant field.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills for clinical development.
• Experience with CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulations.
• Ability to work independently and lead CRO programming deliverables.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides, and define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical data analyses.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, submissions, publications and DSUR.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendors.
• Collaborate with internal and external partners to meet project goals.
• Review SOPs and work instructions related to statistical programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Communication

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role dedicated to a pharmaceutical client. You will lead programming for SDTM/ADaM, develop complex datasets and reports, and ensure regulatory submissions meet FDA/ICH guidelines.

Independent worker with CRO oversight and strong communication is essential. Required 7+ years in biostatistics programming, expertise in CDISC standards, and a degree in a relevant field.