Associate Director, Biostatistics
Core
Leads full scope of statistical contribution to clinical development programs, defining strategies for trials and regulatory submissions.
Role type
Senior IC biostatistician (clinical development leadership)
Builds
Clinical trial statistical plans, regulatory submission packages, and analysis results for immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapies.
Domain
Biopharmaceuticals / Clinical Development / Biostatistics
Required skills
Advanced statistical methodologies, regulatory submission leadership, CRO management, clinical development strategy, study design, quantitative evaluation, statistical programming (SAS/R)
Preferred skills
Innovation in statistical methods, interaction with major regulatory authorities, CRO experience, track record of innovation
Technologies
SAS, R
Responsibilities
Define statistical strategy for clinical trials and regulatory submissions; lead statistical conduct for therapeutic area programs; collaborate on clinical development plans and governance; manage outsourcing operations and CRO deliverables; represent biostatistics in regulatory interactions; interpret analysis results for reports; prepare abstracts and presentations for stakeholders.
Seniority
Senior, hands-on IC with leadership responsibilities