Director, Biostatistics, WCH
Core
Provide statistical leadership and accountability for late-stage nephrology clinical development projects, overseeing evidence generation and regulatory submissions.
Role type
Senior management biostatistics director (clinical development)
Builds
Clinical development plans, protocols, analysis plans, clinical study reports, and regulatory submission materials
Domain
Biotechnology / Clinical Trials / Nephrology
Required skills
Statistical principles, clinical trial methodology, late-stage clinical development strategy, regulatory guidance (FDA/international), medical/biological terminology, project leadership, staff development
Preferred skills
Regulatory submission experience (BLA/NDA/MAA), nephrology or immunology therapeutic area, people management track record
Technologies
None stated
Responsibilities
Develop and direct overall statistical activities for assigned projects; Provide guidance and support for biostatisticians through supervision and coaching; Represent biostatistics on project teams and governance meetings; Provide input into clinical development plans and regulatory submissions; Lead initiatives for clinical development innovation and process improvement; Provide broader mentoring and leadership to achieve organizational goals
Seniority
Director, Management