Senior Statistical Programmer/Analyst Consultant (Hybrid at NJ/PA)
Core
Senior Statistical Programmer delivering technical programming and information components for clinical studies and projects.
Role type
Senior IC statistical programmer (clinical)
Builds
Clinical study deliverables (programming outputs)
Domain
Clinical research / pharmaceutical development
Required skills
Statistical programming, CDISC standards, ICH guidelines, GCP, clinical trial process knowledge, regulatory requirements, specifications writing, documentation oversight, best practices development, automation usage, risk management, stakeholder communication
Preferred skills
Master's degree in CS/statistics, 6+ years clinical programming experience
Technologies
CDISC, ICH, GCP
Responsibilities
Support programming deliveries of clinical studies, implement statistical programming aspects of protocols, ensure high quality in deliverables, program independently with efficiency, write/implement specifications, oversee documentation completeness, contribute to best practices, ensure compliance with standards and automation, plan/support team activities, communicate/escalate risks, work with study team members (Statistician, Lead Programmer, Data Manager, Study Leader)