Principal Statistical Programmer (Remote) - SAS & R Lead

VKB Agriculture; South Africa; Remote; ZAR 1,983,000 - 2,809,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work with a sponsor-backed pharmaceutical client. You will implement reporting and analysis activities across trials, generate SDTM/ADaM datasets, and lead CRO programming deliverables with minimal supervision.

The role requires strong SAS/R programming, CDISC standards, and regulatory submission experience, along with leadership and independent work capabilities. Remote opportunity with global collaboration.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development.
• Expert SAS programming and clinical data reporting experience.
• Extensive CDISC SDTM/ADaM/Define.xml and FDA/ICH knowledge.
• Experience with regulatory submissions and CRO oversight.
• Ability to work independently and lead teams.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs for clinical studies.
• Oversee CRO programmers to meet timelines and quality standards.
• Support CSRs, regulatory submissions, publications, and DSURs.
• Adhere to FDA regulations and GCP guidelines.
• Contribute to standards, tools, and macros development.
• Develop CRFs, edit checks, and data validation plans.
• Prepare data transfer specs for external vendors.
• Collaborate with CROs, vendors, and partners to hit milestones.
• Review and/or author SOPs and Work Instructions.

Skills

SAS programming

R programming

CDISC standards (SDTM/ADaM)

FDA/ICH regulation knowledge

Leadership

Communication

Independent work

Data analysis

Education

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

Tools

SAS

R

Python

Git

Unix/Linux

Shiny

Define.xml

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work with a sponsor-backed pharmaceutical client. You will implement reporting and analysis activities across trials, generate SDTM/ADaM datasets, and lead CRO programming deliverables with minimal supervision.

The role requires strong SAS/R programming, CDISC standards, and regulatory submission experience, along with leadership and independent work capabilities. Remote opportunity with global collaboration.