The role involves collaborating with study teams to design data structures and lead production efforts for clinical trial deliverables including ADaM datasets and submission content
Job Summary
The role involves collaborating with study teams to design data structures and lead production efforts for clinical trial deliverables including ADaM datasets and submission content.
Candidates must possess an in-depth understanding of regulatory requirements such as GCP and ICH while ensuring high-quality, accurate data for authorities.
CSL Seqirus is a global biotherapeutics leader driven by a mission to save lives through innovative therapies and a culture of inclusion and belonging.
Matching Summary
The role involves collaborating with study teams to design data structures and lead production efforts for clinical trial deliverables including ADaM datasets and submission content.
Skills & Requirements
Must-have
8+ years clinical programming experience
Advanced SAS software and macro development
Deep knowledge of CDISC SDTM and ADaM standards
Leadership of pooled and exploratory analyses
Experience with CRO oversight and validation
Nice-to-have
Presentation at professional conferences
Development of global efficiency tools
Cross-functional multicultural team collaboration
Strategic planning and organizational skills
Key Requirements
BSc in Computer Science, Mathematics, or Statistics
Minimum 8 years of clinical/statistical programming experience
Extensive experience with SAS Macros and statistical analysis
Proven ability to work independently and manage timelines