Principal Statistical Programmer - Remote (SAS + R)

Absolute Pets (Pty) Ltd.; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote engagement embedded with a pharmaceutical client. You will lead programming activities, ensure SDTM/ADaM specifications, and deliver high-quality datasets, tables, listings, and figures in support of regulatory submissions.

You will work with CROs and internal teams, stay compliant with FDA/ICH guidelines, and mentor junior programmers while driving efficiency and standards across studies.

Qualifications

• Minimum 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 Biometrics Team or similar.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and regulatory knowledge (FDA/ICH).
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently; strong written and spoken communication and leadership skills.

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 complex graphs.
• Deliver high-quality SAS and/or R programming outputs for clinical development programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Follow FDA regulations, GCP, and electronic submission guidelines.
• Create and maintain standards for programming tools, outputs, and macros.
• Contribute to CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal and CRO partners to meet project goals and timelines.
• Draft SOPs and work instructions related to statistical programming.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Regulatory submissions

CRO oversight

Leadership

Communication skills

Independent work

Clinical programming

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote engagement embedded with a pharmaceutical client. You will lead programming activities, ensure SDTM/ADaM specifications, and deliver high-quality datasets, tables, listings, and figures in support of regulatory submissions.

You will work with CROs and internal teams, stay compliant with FDA/ICH guidelines, and mentor junior programmers while driving efficiency and standards across studies.