Associate Director / Director, Biostatistics
EPM Scientific - Phaidon International - Newark, New Jersey, us, 07175
Work at EPM Scientific - Phaidon International
Overview
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Overview
Associate Director / Director, Biostatistics Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field (Mathematics). Minimum of 4+ years of relevant industry experience. Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions / filings.
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