Statistical scientist

Role Overview: The ideal candidate for the Biostatistician role should possess a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is also a preferred qualification. With at least 9+ years of experience, you must demonstrate a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. As a Biostatistician, you will be an integral part of cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your role will involve collaborating 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. Key Responsibilities: - Drive the selection of optimal study designs, data collection methods, and analytic approaches - Provide strategic and scientific input at the indication/protocol/integrated analysis level - Develop a broad understanding of the clinical, regulatory, and commercial landscape - Prepare the development strategy to facilitate the effective and safe utilization of the product - Collaborate with clinical and regulatory partners, external opinion leaders, and other team members - Lead the development and execution of statistical aspects for multiple complex studies independently - Play a key role in filing activities, including planning and executing integrated analyses - Defend protocols and Statistical Analysis Plans (SAPs) during reviews and provide independent assessments Qualifications Required: - Master's degree in Statistics or equivalent - Ph.D. in Statistics or equivalent with 6+ years of industry-related experience - Deep understanding of statistical and clinical trials methodology - Excellent communication skills - Ability to uphold quality standards, adherence to processes and SOPs - Continuous learning of applied statistical methodology (Note: No additional details about the company were provided in the job description),