Remote Principal Statistical Programmer - SAS/R Expert

Blacksmith Agency Llc; South Africa; Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs for a global pharmaceutical client.

You will implement reporting and analysis activities, lead programming efforts, and oversee CROs to ensure high-quality data deliverables in alignment with FDA/ICH guidelines. The role requires 7+ years in biotech/pharma programming, strong SAS skills, and CDISC expertise; experience with R and other tools is preferred.

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.
• Exceptional SAS programming skills with clinical development experience.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulatory knowledge.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, listings, tables and graphs, including descriptive and inferential statistics.
• Deliver high-quality programming results and maintain SAS and/or R programs.
• Oversee CROs' programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and exploratory analyses.
• Ensure compliance with FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; provide data transfer specs.
• Collaborate with internal/external partners to meet project timelines and goals.
• Review and/or author SOPs and Work Instructions related to statistical programming practices.

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

CDISC SDTM

CDISC ADaM

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs for a global pharmaceutical client.

You will implement reporting and analysis activities, lead programming efforts, and oversee CROs to ensure high-quality data deliverables in alignment with FDA/ICH guidelines. The role requires 7+ years in biotech/pharma programming, strong SAS skills, and CDISC expertise; experience with R and other tools is preferred.