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As the Director of Biostatistics, you will lead statistical support for both early- and late-phase clinical studies, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards. This role requires strong statistical and cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company’s goals.
Job Responsibility:
Lead statistical efforts for early-to-late phase clinical studies, key regulatory, and submission activities
Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams
Lead the development and the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource utilization, and increase the probability of success
Ensure the accuracy, integrity, and consistency of statistical analyses across all clinical development programs, from Phase I through regulatory submissions and post-approval activities
Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization
Requirements:
Advanced degree (PhD/MS) in Biostatistics or Statistics
PhD: Minimum of 8+ years of relevant experience
MS: Minimum of 10+ years of relevant experience
Successful experience in regulatory submissions, including NDAs, BLAs, and other filings
Strong leadership in statistical activities supporting clinical development programs
Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
Hands-on expertise with statistical software (e.g., SAS, R) and familiarity with CDISC standards
Strong problem-solving and strategic thinking skills, with the ability to translate complex statistical concepts into actionable insights for diverse stakeholders
Excellent communication and interpersonal skills, with the ability to influence decision-making and foster collaboration across functions
Extensive leadership experience in overseeing CRO activities