Senior Statistical Programmer (SAS + R) – Remote Pharma

V&Vn Longverpleegkundigen; South Africa; Remote; ZAR 1,000,000 - 1,500,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely, embedded with a pharmaceutical client, delivering data analyses and reporting for multiple studies.

You will generate SDTM/ADaM specs, write SAS and R programs, oversee CRO deliverables, support regulatory submissions, and ensure compliance with FDA/ICH guidelines. Independent, experienced, and collaborative.

This role offers autonomy and a leadership path within a globally integrated biostatistics team.

Qualifications

• Bachelor's degree in a quantitative field and 7+ years of statistical programming in biotech/pharma.
• Exceptional SAS programming skills and CDISC standards experience.
• Experience supporting regulatory submissions and FDA/ICH guidelines.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming results using SAS and R.
• Oversee CRO statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs, and exploratory analyses.
• Understand and follow FDA regulations for reporting clinical trial data (GCP, eCTD).
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review and/or author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals.
• Provide review and/or author SOPs and work instructions for statistical programming.

Skills

SAS programming

CDISC SDTM/ADaM

R programming

Regulatory submissions

Independent work

Leadership

Education

Bachelor's degree in CS/DS/Math/Stats

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely, embedded with a pharmaceutical client, delivering data analyses and reporting for multiple studies.

You will generate SDTM/ADaM specs, write SAS and R programs, oversee CRO deliverables, support regulatory submissions, and ensure compliance with FDA/ICH guidelines. Independent, experienced, and collaborative.

This role offers autonomy and a leadership path within a globally integrated biostatistics team.