Principal Statistical Programmer – SAS & R (Remote)

Sanlam Limited; South Africa; Remote; ZAR 1,990,000 - 3,150,000; Full time

Benefits offered by this job

Remote work

Sponsor-dedicated role

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs across therapeutic areas.

You will implement reporting and analysis activities, develop SDTM/ADaM datasets, and oversee CRO programmers to ensure high-quality, timely deliverables while aligning with FDA/ICH regulations. You will work independently with minimal supervision, reporting to the Director, Biostatistics and Programming, in the FSP Services unit, and interact with sponsor

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills and CDISC (SDTM/ADaM/Define.xml) expertise.
• Experience supporting regulatory submissions and FDA/ICH regulations.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, complex listings, tables and graphs.
• Deliver high-quality SAS/R outputs and validate programming procedures.
• Oversee CROs' programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions and analyses.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with internal/external partners to ensure project goals.

Skills

SAS programming

Leadership

Communication

Independent worker

FDA/ICH knowledge

Education

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

Tools

R

Python

Git

Unix/Linux

Shiny

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on clinical development programs across therapeutic areas.

You will implement reporting and analysis activities, develop SDTM/ADaM datasets, and oversee CRO programmers to ensure high-quality, timely deliverables while aligning with FDA/ICH regulations. You will work independently with minimal supervision, reporting to the Director, Biostatistics and Programming, in the FSP Services unit, and interact with sponsor