Director Biostatistics

Role: Senior biostatistician supporting clinical development as a compound/indication lead for early and late-stage biologics or targeted therapies in oncology. Responsibilities include acting as the primary statistical contact, contributing to development strategies, engaging with regulatory authorities, ensuring consistency of statistical methods, and supporting integrated data analyses for submissions and regulatory interactions. The role involves active participation in cross-functional teams, representing the company at conferences and regulatory meetings, overseeing vendor collaborations, and ensuring adherence to ICH-GCP and SDISC standards. Requirements: Master’s or PhD in statistics or related field; 12+ years of relevant experience, including experience with biologics, targeted therapies, regulatory submissions (FDA, EMA, ICH), and clinical trial design (including adaptive and modeling techniques). Preferred skills include expertise with SDTM, ADaM, eSUB, and experience leading complex projects and teams. HighValue: biologics, targeted therapies, oncology, early and late-phase development, regulatory interactions, statistical modeling, vendor oversight, cross-functional collaboration, international regulatory standards. WorkSetup: not specified.