Senior Principal Statistical Programmer — Remote (SAS + R)

Placements24; Rustenburg; Remote; ZAR 900.000 - 1.500.000; Vollzeit

Zusammenfassung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated engagement within one pharmaceutical client. You will lead programming activities, implement CDISC standards, and oversee CRO outputs with autonomy and ownership.

You will develop SAS/R programs, generate SDTM/ADaM, define.xml, and supporting documentation for regulatory submissions, while ensuring compliance with FDA/ICH guidelines. Strong leadership and communication are essential.

Qualifikationen

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma
• Extensive CDISC SDTM/ADaM and Define.xml knowledge
• Experience supporting regulatory submissions to FDA/global authorities
• Strong problem-solving and communication skills; able to work with minimal supervision
• Proficient in SAS; knowledge of R and other tools is a plus
• Ability to supervise CRO programmers and ensure timely data delivery

Aufgaben

• Generate SDTM, ADaM specifications, datasets, and define.xml for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality SAS/R programming outputs for clinical trials
• Oversee CRO programming deliverables and timelines
• Support creation of SD, CSRs, regulatory submissions, DSURs, and analyses
• Ensure compliance with FDA/ICH guidelines for electronic submissions
• Collaborate with internal/external partners to meet project goals
• Develop and maintain programming standards, tools, and macros

Kenntnisse

SAS programming

CDISC

Regulatory submissions

Independent worker

Leadership

Communication

R

Python

Unix/Linux

Git

Ausbildung

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Jobbeschreibung

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated engagement within one pharmaceutical client. You will lead programming activities, implement CDISC standards, and oversee CRO outputs with autonomy and ownership.

You will develop SAS/R programs, generate SDTM/ADaM, define.xml, and supporting documentation for regulatory submissions, while ensuring compliance with FDA/ICH guidelines. Strong leadership and communication are essential.