Remote Principal Statistical Programmer SAS + R

Placements24; Gauteng; Remote; ZAR 1.997.000 - 2.995.000; Vollzeit

Zusammenfassung

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R for remote work embedded with a pharmaceutical client. You will lead statistical programming activities across SDTM/ADaM, define.xml, and regulatory submissions, with CRO oversight and strong autonomy.

The role emphasizes high-quality data deliverables, FDA/ICH compliance, and collaboration with cross-functional teams in a fully remote, sponsor-dedicated environment.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred)
• 7+ years as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics
• Exceptional SAS programming skills for clinical development environments
• Extensive: CDISC standards (SDTM, ADaM, Define.xml), medical terminology, FDA/ICH regulations
• Experience supporting regulatory submissions and interactions with FDA/global authorities
• Ability to work independently and lead with strong communication and leadership
• Nice-to-have: experience with pharmacokinetics, neuroscience; proficiency in R/Python/Java/Unix/Linux/git

Aufgaben

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml for multiple studies
• Develop SAS programs to create datasets, complex listings, tables, and graphs
• Deliver high-quality SAS and/or R programs for clinical development needs
• Oversee CRO programming deliverables to meet timelines and quality
• Assist in preparing clinical study reports, regulatory submissions, publications and DSURs
• Ensure compliance with FDA regulations and good clinical practice for data submissions
• Contribute to standards for programming tools, outputs, and macros
• Help develop CRFs, edit checks, and data validation plans
• Provide review/author data transfer specifications for external vendors
• Collaborate with internal/external partners to meet project goals
• Review/author SOPs and work instructions for programming practices

Kenntnisse

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Independent work

R

Python

Unix/Linux

Define.xml

Ausbildung

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

Tools

SAS

R

Python

Unix/Linux

Git

Jobbeschreibung

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R for remote work embedded with a pharmaceutical client. You will lead statistical programming activities across SDTM/ADaM, define.xml, and regulatory submissions, with CRO oversight and strong autonomy.

The role emphasizes high-quality data deliverables, FDA/ICH compliance, and collaboration with cross-functional teams in a fully remote, sponsor-dedicated environment.