Senior Biostatistician

As a Biostatistician at the company, you will play a vital role in cross-functional development teams by contributing to various aspects of trial design, protocol development, analysis planning, interpretation of results, and regulatory submissions. Your main responsibilities will include: - Developing collaborative relationships with team members such as the GBDS Biostatistics Lead, medical monitor, protocol manager, data manager, and PK scientist. - Making strategic and scientific contributions at the indication/protocol/integrated analysis level to enhance understanding of the asset being studied. - Driving the selection of optimal study designs, data collection methods, analytic approaches, and interpretation of trial data. - Interacting with external vendors, key opinion leaders, and regulatory agencies. - Expanding expertise by researching medical literature and regulatory documents. You will also be tasked with: - Contributing to the development strategy to ensure effective and safe product utilization. - Designing innovative and efficient clinical trials, selecting study populations and endpoints. - Translating scientific questions into statistical terms and vice versa. - Ensuring all analyses have clearly articulated hypotheses and are supported by trial design and data. - Effectively communicating with clinical, regulatory partners, and external opinion leaders. - Collaborating with clinicians and medical writers to prepare summaries for regulatory documents and scientific articles. Furthermore, you will be involved in: - Authoring and/or reviewing various study level documents such as protocol synopsis, statistical analysis plan, clinical study reports. - Employing cost-disciplined science in trial sizing and analysis planning. - Ensuring compliance with company processes, global standards, and maintaining deliverable quality. - Leading statistical aspects for multiple or complex studies independently. - Leading filing activities, including planning and executing integrated analyses. Your contributions will be essential in ensuring alignment at the study team level and maintaining quality in all assignments associated with the assigned protocol or project. It is expected that you stay updated with the latest applied statistical methodology and have a good understanding of CDISC standards and implementation guides.,