Sr Manager, Statistical Programming
Core
Lead statistical programming and analysis for clinical study reports and regulatory submissions in oncology, hematology, virology, and inflammation.
Role type
Senior Manager, Statistical Programming
Builds
Regulatory submission packages (NDA, BLA, MAA) and integrated summaries for FDA, PMDA, EMA, and other global agencies.
Domain
Pharmaceutical clinical trials and regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming and macro development, CDISC standards (CDASH, SDTM, ADaM), clinical trial design and reporting, regulatory submission processes, project management, resource planning, cross-functional collaboration
Preferred skills
Oncology/hematology/virology/inflammation therapeutic area experience, pivotal study experience, complex fast-turnaround programming, strategic initiative implementation
Technologies
SAS, CDISC standards
Responsibilities
Direct design and coding of analysis files, generate tables/figures/listings for study reports, anticipate resource needs, resolve study-related issues, negotiate timelines, implement strategic initiatives
Seniority
Senior Manager, hands-on IC with team leadership
