Principal Statistical Programmer — SAS + R (Remote)

Curro Holdings Ltd; South Africa; Remote; ZAR 1,100,000 - 1,600,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client.

You will lead SDTM/ADaM programming, develop complex SAS and R analyses, and supervise CRO programmers to assure timely, compliant data outputs for regulatory submissions. You should have 7+ years of industry experience, strong leadership and communication skills, and a deep understanding of CDISC standards and FDA/ICH guidelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics preferred.
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Biometric team or similar.
• Exceptional SAS programming skills for clinical development environments.
• Extensive experience with CDISC SDTM/ADaM and Define.xml; FDA/ICH familiarity.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and deliver high-quality outputs.
• Strong written/verbal communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS and R programs tailored to clinical development needs.
• Oversee CRO programmers to ensure timely, high-quality outputs.
• Support preparation of study reports, regulatory submissions, publications, DSURs and analyses.
• Follow FDA regulations and pharmacovigilance guidelines for submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

SAS programming

SDTM/ADaM

CDISC standards

Regulatory submissions

Leadership

Communication

R

Education

Bachelor's degree in computer science or related field

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client.

You will lead SDTM/ADaM programming, develop complex SAS and R analyses, and supervise CRO programmers to assure timely, compliant data outputs for regulatory submissions. You should have 7+ years of industry experience, strong leadership and communication skills, and a deep understanding of CDISC standards and FDA/ICH guidelines.