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Senior Manager, Biostatistics

iovance biotherapeutics·US·United States·senior
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Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Senior Manager, Biostatistics provides statistical leadership for complex clinical studies in cell therapy oncology programs. This role is responsible for study design, statistical analysis, interpretation of results, and communication of statistical findings. Working independently with minimal supervision, the Senior Manager, Biostatistics serves as the lead statistician for assigned studies, collaborates with cross-functional project teams, and oversees statistical activities performed by contract research organizations (CROs) to ensure high-quality and timely deliverables. Essential Functions and Responsibilities Serves as lead statistician for one or more clinical studies and may support program-level statistical strategy. Leads statistical activities for assigned studies and collaborates with statistical programmers and CRO partners to ensure timely delivery of high-quality statistical outputs. Authors and reviews statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications including abstracts and posters. Maintains current knowledge of statistical methodologies, regulatory guidance, and industry best practices relevant to oncology drug development. May contribute statistical expertise to due diligence activities and cross-functional evaluations when needed. Creates networks with external