Remote Principal Statistical Programmer (SAS + R) Leader

Shopritex; South Africa; Remote; ZAR 2,313,000 - 3,305,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated team remotely. You will develop SDTM/ADaM specs, write SAS programs, and supervise CRO outputs to ensure high-quality data, analyses and regulatory submissions across trials.

The role requires 7+ years in biotech/pharma programming, strong SAS, CDISC standards and experience with FDA/ICH guidelines. Independent work, leadership, and excellent communication are essential.

Qualifications

• Bachelor's degree in CS/Data Science/Statistics or related field.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development.
• Expert SAS programming and SDTM/ADaM/Define.xml proficiency.
• Experience with regulatory submissions and FDA/ICH guidelines.

Responsibilities

• Generate SDTM/ADaM specs, datasets, define.xml and reviewer’s guide.
• Develop SAS programs for datasets, listings, tables and graphs.
• Oversee CRO programmers to ensure high quality and timelines.
• Support regulatory submissions, publications and DSURs.
• Conform to FDA regulations and GCP for electronic submissions.
• Create and validate programming standards, CRFs and data validation plans.
• Draft data transfer specs and SOPs for statistical programming practices.

Skills

years of experience

SAS programming

CDISC standards (SDTM/ADaM/Define.xml)

regulatory submissions experience

independent work

leadership / communication skills

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R to join a sponsor-dedicated team remotely. You will develop SDTM/ADaM specs, write SAS programs, and supervise CRO outputs to ensure high-quality data, analyses and regulatory submissions across trials.

The role requires 7+ years in biotech/pharma programming, strong SAS, CDISC standards and experience with FDA/ICH guidelines. Independent work, leadership, and excellent communication are essential.