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).