4.0 - 8.0 years

0 Lacs

karnataka

On-site

As a Biostatistician at our organization, you will play a crucial role in contributing to cross-functional development teams, aiding in trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your responsibilities will involve collaborating with various team members including the Global Biometric Sciences Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other study/indication team members. Your role will require you to provide strategic and scientific input at the indication/protocol/integrated analysis level, thereby enhancing the understanding of the asset under study, improving development decisions, and increasing the chances of regulatory and market success. Stakeholder management will be a significant part of your responsibilities, involving interactions with business partners within your team, as well as external vendors, key opinion leaders, and regulatory agencies. You will need to extend your expertise beyond biostatistics by delving into the medical literature and regulatory documents to gain a comprehensive understanding of the clinical, regulatory, and commercial landscape. Additionally, you will contribute to the development strategy to ensure effective and safe utilization of the product. Driving the design of innovative and efficient clinical trials, selecting study populations, and endpoints, and translating scientific questions into statistical terms will be among your key tasks. Your role will involve challenging collaborator assumptions based on facts, providing insights, and ensuring that all analyses conducted have clearly articulated hypotheses associated with them. Effective communication with clinical and regulatory partners, as well as external opinion leaders, will be essential. You will also be responsible for authoring and/or reviewing various study-level documents such as protocol synopsis, statistical analysis plan, clinical study reports, and publications. Compliance with organizational processes and standards, ensuring quality deliverables, and collaborating with clinicians and medical writers to prepare summaries of results will be part of your routine tasks. You will lead the development and execution of statistical aspects for multiple or complex studies independently, as well as play a crucial role in filing activities and defending protocols and Statistical Analysis Plans (SAPs) at reviews. To excel in this role, you must keep abreast of state-of-the-art applied statistical methodology, understand CDISC standards and implementation guides, and ensure quality in all planning, design, and execution of assignments associated with the assigned protocol or project. Your ability to drive alignment at the study team level and provide statistical consultation for ad hoc analysis requests will be key to your success in this position.,

Posted 1 week ago

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