Biostatistics Director

Role Overview The Director is a key statistical expert supporting clinical development, serving as compound and/or indication lead for early and late-stage programs, or as trial responsible statistician. They contribute to clinical strategies, ensuring scientific and regulatory compliance, and act as a role model for best practices. Key Responsibilities Lead statistical activities for designated compounds/indications, ensuring methodological consistency and sharing information across trials.Engage with regulatory authorities and represent the organization at scientific meetings, contributing to development strategies and submissions.Support integrated database development, analysis planning, and scientific communication efforts.Participate in trial design, protocol review, vendor oversight, and review of statistical analysis plans, reports, and regulatory documents.Collaborate on external vendor qualification, data transfer, and regulatory submission activities.Mentor teams, provide expert advice on advanced statistical methodologies, and ensure compliance with industry standards and regulations. Qualifications & Skills Master’s or PhD in a statistical discipline.Extensive experience (preferably 12+ years) in drug development, statistical analysis, modeling, and adaptive trial designs.Experience with biologics, targeted therapies, and regulatory agencies like FDA, EMA, ICH guidelines.Proficiency with SDTM, ADaM, CDISC standards, and regulatory submissions.Leadership skills in managing multiple complex projects and mentoring teams. This role demands a strategic thinker with strong regulatory knowledge, excellent communication, and leadership abilities to drive innovative clinical development efforts.