Biostatistics Director

Role Overview: The Director is a statistical expert supporting clinical development as a lead or trial statistician for early and late-stage programs, contributing to strategies and plans. Key Responsibilities Serve as the primary statistical contact for designated compounds/indications, ensuring methodological consistency and sharing information across trials.Engage with regulatory authorities and participate in discussions at compound/indication and trial levels.Provide scientific advice on trial design, analysis, and advanced statistical methodologies.Support integrated database development, conduct analyses, and contribute to scientific communications.Represent the organization at conferences, KOL meetings, and regulatory interactions.Oversee vendor qualification, collaborate on CRO activities, and support regulatory submissions. Qualifications & Skills Master's or PhD in a statistical discipline.12+ years of relevant experience, including statistical analysis, modeling, and adaptive designs.Experience with biologics, targeted therapies, and regulatory guidance (FDA, EMA, ICH).Proficiency with SDTM, ADaM, CDISC standards, and regulatory submission processes.Strong leadership, project management, and mentoring skills. Additional Information: The role involves representing statistical expertise across multiple levels, ensuring compliance with standards, and supporting development and regulatory activities to advance innovative antibody medicines.