6.0 - 10.0 years

0 Lacs

karnataka

On-site

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, the candidate 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. Your responsibilities will include driving the selection of optimal study designs, data collection methods, and analytic approaches. You will be expected to provide strategic and scientific input at the indication/protocol/integrated analysis level to enhance the understanding of the asset being studied and improve development decisions. In addition to your statistical expertise, you will need to develop a broad understanding of the clinical, regulatory, and commercial landscape by researching medical literature and regulatory documents. You will be responsible for preparing the development strategy to facilitate the effective and safe utilization of the product. Furthermore, you must possess excellent communication skills to effectively collaborate with clinical and regulatory partners, external opinion leaders, and other team members. Your role will involve authoring or reviewing various study-level documents such as protocol synopsis, statistical analysis plan, clinical study reports, and publications. As a seasoned Biostatistician, you will be expected to lead the development and execution of statistical aspects for multiple complex studies independently. You will also play a key role in filing activities, including planning and executing integrated analyses. Your ability to defend protocols and Statistical Analysis Plans (SAPs) during reviews and provide independent assessments will be crucial in this role. Overall, your contributions 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.,

Posted 1 month ago

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