Statistical scientist

As a Biostatistician, you will play a crucial role in contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. You will collaborate with various stakeholders such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Your responsibilities will include: - Driving the selection of optimal study designs, data collection methods, and analytic approaches. - Providing strategic and scientific input at the indication/protocol/integrated analysis level to enhance the understanding of the asset being studied and improve development decisions. - Developing a broad understanding of the clinical, regulatory, and commercial landscape by researching medical literature and regulatory documents. - Preparing the development strategy to facilitate the effective and safe utilization of the product. - Leading the development and execution of statistical aspects for multiple complex studies independently. - Playing a key role in filing activities, including planning and executing integrated analyses. - Defending protocols and Statistical Analysis Plans (SAPs) during reviews and providing independent assessments. Qualifications required for this role include: - Possession of a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is preferred. - At least 9+ years of experience demonstrating a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. Your role as a Biostatistician will significantly impact the success of clinical trials, regulatory submissions, and market access strategies. Your dedication to upholding quality standards, adherence to processes and SOPs, and continuous learning of applied statistical methodology will be key to your success in this role.,