Principal Statistical Programmer - Remote (SAS & R)

Hr Management & Support Services; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to independently drive statistical programming for sponsor-driven clinical programs.

You will develop SDTM/ADaM specifications, datasets, and defines/xmls, while supervising CRO programmers to ensure timely, high-quality outputs across multiple studies. Ideal candidates have 7+ years in Biotech/Pharma, expert SAS/SDTM experience, and a solid track record with FDA/ICH regulations and regulatory submissions.

Qualifications

• Bachelor's degree required in a quantitative field.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead with strong communication 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 with descriptive and inferential statistics.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs for clinical development needs.
• Oversee CRO programming deliverables across studies to ensure quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership / CRO oversight

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to independently drive statistical programming for sponsor-driven clinical programs.

You will develop SDTM/ADaM specifications, datasets, and defines/xmls, while supervising CRO programmers to ensure timely, high-quality outputs across multiple studies. Ideal candidates have 7+ years in Biotech/Pharma, expert SAS/SDTM experience, and a solid track record with FDA/ICH regulations and regulatory submissions.