Lead Statistical Programmer (SAS & R) – Remote

Department Of Education Tasmania; South Africa; Remote; ZAR 1,997,000 - 2,662,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical projects, driving SDTM/ADaM data delivery and complex analyses. You will develop SAS and R programs, review deliverables, and guide CROs to ensure high-quality, on-time outputs.

The role requires extensive CDISC knowledge, FDA/ICH experience, and strong communication. You will contribute to study reports, regulatory submissions, and data standards while working with autonomy under senior leadership.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills with CDISC SDTM/ADaM and Define.xml experience.
• Experience supporting regulatory submissions and FDA/ICH regulation.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and Define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs in collaboration with a Statistician.
• Oversee CROs’ statistical programming deliverables to ensure high quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Ensure compliance with FDA regulations and GCP in reporting clinical trial data.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH compliance

Regulatory submissions

Communication skills

Education

Bachelor's degree in CS/Math/Statistics

Tools

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical projects, driving SDTM/ADaM data delivery and complex analyses. You will develop SAS and R programs, review deliverables, and guide CROs to ensure high-quality, on-time outputs.

The role requires extensive CDISC knowledge, FDA/ICH experience, and strong communication. You will contribute to study reports, regulatory submissions, and data standards while working with autonomy under senior leadership.