Biostatistics Director

Role Overview The Director of Biostatistics serves as a statistical expert supporting the clinical development of antibody-based therapies, leading statistical activities across early and late-stage programs. They contribute to development strategies, ensuring consistency, and engaging with regulatory authorities on scientific and technical discussions. Key Responsibilities Act as the primary statistical contact for designated compounds/indications, overseeing methodology and data handlingProvide scientific input on trial design, analysis plans, and advanced statistical techniquesRepresent the organization at regulatory meetings, Key Opinion Leaders, and scientific conferencesEnsure proper documentation, data integrity, and adherence to regulatory standards (ICH-GCP, SOPs)Participate in vendor oversight, CRO collaboration, and submission activitiesLead and mentor biostatistics teams, supporting regulatory filings and strategic planning Qualifications & Skills: Master's or PhD in statistics or related field12+ years of relevant experience, with expertise in modeling, adaptive trial designs, and biologics developmentKnowledge of FDA, EMA, ICH guidelines, and regulatory submission processesExperience with SDTM, ADaM, and CDISC standardsStrong leadership, communication, and project management skills