Principal Statistical Programmer — SAS + R (Remote)

Placements24; Rustenburg; Remote; ZAR 900,000 - 1,700,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on Sponsor projects within our FSP Services. You will implement reporting and analysis activities for clinical trials across multiple therapeutic areas, with autonomy and accountability.

You will generate SDTM/ADaM specifications and define.xml, develop SAS and R programs, oversee CRO deliverables, and support regulatory submissions in line with FDA/ICH guidelines.

Qualifications

• Minimum bachelor’s degree in a quantitative field (computer science, data science, mathematics or statistics)
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development
• Exceptional SAS programming skills and experience with CDISC standards (SDTM/ADaM/Define.xml)
• Experience supporting regulatory submissions with FDA/ICH
• Ability to work independently and meet timelines
• Strong communication and leadership skills
• Nice to have experience with pharmacokinetics and neuroscience, and with R/Python/Java/Shiny/Unix
• Proficient in development and validation of programming standards and tools

Responsibilities

• Generate SDTM and ADaM specifications and datasets
• Develop SAS programs to produce listings, tables and graphs
• Deliver high-quality SAS/R outputs for clinical development programs
• Oversee CRO programmers to ensure timely, compliant deliverables
• Support clinical study reports and regulatory submissions
• Create, validate and maintain programming standards and macros
• Develop CRFs, edit checks and data validation plans
• Collaborate with CROs and vendors to meet project timelines

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Education

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

Tools

SAS

R

Unix/Linux

git

Python

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on Sponsor projects within our FSP Services. You will implement reporting and analysis activities for clinical trials across multiple therapeutic areas, with autonomy and accountability.

You will generate SDTM/ADaM specifications and define.xml, develop SAS and R programs, oversee CRO deliverables, and support regulatory submissions in line with FDA/ICH guidelines.