Senior Director Biostatistics
Core
Shape statistical strategy for innovative clinical development programs, influencing study design, regulatory submissions, and key development decisions while leading a global team of statisticians.
Role type
Senior Director Biostatistics (Strategic Leadership & Hands-on IC)
Builds
Clinical development programs and regulatory submissions for pharmaceutical/biotech products
Domain
Healthcare / Clinical Trials / Biostatistics
Required skills
Strategic statistical leadership, Clinical trial design (Phase II-IV), Regulatory submission expertise, Team leadership & mentoring, SAS, R, CDISC standards (SDTM, ADaM), GCP/ICH compliance
Preferred skills
External publication authorship, Cross-functional collaboration
Technologies
SAS, R, CDISC (SDTM, ADaM)
Responsibilities
Provide strategic statistical leadership for clinical development programs; Lead, inspire, and coach a small global team of Statisticians; Lead statistical design, analysis, interpretation and communication of clinical trial data; Review protocols, SAPs, CSRs, and provide guidance on regulatory submissions; Oversee statistical deliverables to ensure quality and timely execution; Partner with cross-functional stakeholders; Drive capability building and innovation.
Seniority
Senior Director, Strategic Leadership & Hands-on IC