Remote Principal Statistical Programmer - SAS & R Leader

African Echoes Recruitment; Mbombela (Nelspruit); Remote; ZAR 1,990,000 - 2,985,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, under Cytel support. The role focuses on SDTM/ADaM, SAS, and R programming across trials with CRO oversight and regulatory submission duties.

The ideal candidate has 7+ years in biotech/pharma programming, strong CDISC knowledge, and the ability to lead and communicate effectively in a global environment.

Qualifications

• 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 team.
• Exceptional SAS programming skills for clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory guidelines.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides and define.xmls for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs (with statistics).
• Deliver high-quality SAS/R programming results; validate and maintain programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of CSRs, regulatory submissions, DSURs and exploratory analyses.
• Follow FDA/ICH regulations, GCP, and electronic submission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; collaborate across functions.
• Provide review/author data transfer specifications for external vendors.
• Review and author SOPs and Work Instructions for programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Education

Bachelor's degree in a relevant field

Tools

SAS

R

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, under Cytel support. The role focuses on SDTM/ADaM, SAS, and R programming across trials with CRO oversight and regulatory submission duties.

The ideal candidate has 7+ years in biotech/pharma programming, strong CDISC knowledge, and the ability to lead and communicate effectively in a global environment.