Associate Director / Director, Biostatistics
Core
Provides statistical support for clinical study design, analysis, interpretation, and regulatory submissions in oncology drug development.
Role type
Senior IC biostatistician with leadership responsibilities
Builds
Clinical trial statistical deliverables, regulatory submissions (NDA/BLA), and scientific publications
Domain
Oncology clinical trials and biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biostatistics, clinical trial design, survival analysis, adaptive designs, regulatory submissions, CRO management, CDISC standards, statistical programming (SAS/R), ICH guidelines
Preferred skills
Oncology endpoints, simulation for trial design, people management
Technologies
SAS, R, CDISC (SDTM, ADaM)
Responsibilities
Design statistical analysis plans and interpret clinical trial results; Provide strategic input for clinical development plans and regulatory meetings; Manage vendor performance for outsourced studies; Lead process improvement and training initiatives; Collaborate with cross-functional teams to resolve data issues
Seniority
Director/Associate Director, hands-on IC with team leadership
