Sr Director, Statistical Innovation

Responsibilities

• Provides senior advisory input in the design of therapeutic area and product development strategies, development programs, and clinical studies, in partnership with the Biostatistics TA head, Strategic Development Director, Senior Director-level and Director-level GSLs, EGT functional leaders, and other key stakeholders.
• Drives consideration of conventional and innovative design options and ensures the appropriate design, estimand, and estimator are selected to meet the study and development objectives.
• Provides advanced statistical and methodological advice to Senior Director-level and Director-level GSLs and other key stakeholders on complex issues that may affect major development decisions, regulatory interactions, and filings.
• Guides evaluation of design options by synthesizing and interpreting simulation results, regulatory considerations, operational feasibility, and development objectives.
• Provides design options and simulation specifications to the Simulation and Modeling team and develops, reviews, and approves the simulation plan and results.
• Connects insights and lessons across products and programs within a therapeutic area to promote consistency and broader application of innovative design and analysis approaches.

Qualifications

• Doctorate degree and 5 years of Statistics/Biostatistics or related subjects with high statistical content OR Master’s degree and 9 years of Statistics/Biostatistics or related subjects with high statistical content OR Bachelor’s degree and 11 years of Statistics/Biostatistics or related subjects with high statistical content
• In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above
• At least 12 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting
• Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions
• Strategic statistical leadership at product level of at least one complex program or multiple programs of moderate complexity