Senior Biostatistician

Responsibilities: Provide statistical expertise in the design, analysis, and reporting of clinical studies. Partner with cross-functional teams to define analysis scope and timelines. Develop statistical analysis plans and detailed analysis specifications. Conduct and perform quality control on statistical analyses, including statistical modeling as needed. Collaborate with statistical programming teams to ensure analyses are conducted per plan and specifications. Work with data management and clinical operations to support robust data collection and database development. Contribute to the development and review of scientific publications, ensuring data consistency and accuracy. Author and review statistical sections of regulatory submissions and responses, ensuring clarity and accuracy in data presentation. Represent the biostatistics function on study teams and contribute to cross-functional decision-making. Required Skills, Experience, and Education: Advanced degree (Ph.D. or M.S.) in statistics, biostatistics, or a related field, with relevant industry experience. Experience supporting late-stage onocology clinical development is required. Experience with regulatory submissions and interactions with regulatory agencies is preferred. Proficiency in statistical programming tools (e.g., SAS and/or R). #J-18808-Ljbffr Apr