Position Summary:
As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership role, you will oversee the development, execution, and interpretation of statistical analyses, maintaining data quality, analysis integrity, and compliance with regulatory requirements. Additionally, you will champion innovative trial designs and methodologies while fostering a collaborative, high-performing team culture. Reporting to the VP, Head of Biometrics, you will play a pivotal role in shaping clinical development strategy and achieving company goals.
Key Responsibilities: Build, mentor, and lead a high-performing statistical team, fostering collaboration, learning, and accountability.Provide strategic and statistical leadership as a core member of the clinical development team, collaborating with cross-functional stakeholders.Partner with medical, regulatory, pharmacology, clinical operations, and other functions to implement appropriate statistical methodologies and analysis plans.Champion innovative statistical approaches, such as adaptive, seamless, and Bayesian designs, to enhance trial efficiency and success rates.Ensure the accuracy, integrity, and consistency of statistical analyses across clinical development programs, from Phase I through regulatory submissions and post-approval activities.Contribute to the development and implementation of Standard Operating Procedures (SOPs) and workflows, ensuring regulatory compliance and adherence to industry best practices.Oversee CRO activities, ensuring high-quality deliverables, adherence to timelines, and efficient use of resources.Requirements: Ph.D. in Biostatistics or Statistics with 10+ years of industry experience, or Master's degree with 12+ years of experience.Proven expertise in statistical activities for clinical development programs, including successful regulatory submissions (NDAs, BLAs, or equivalent).Demonstrated leadership in applying innovative statistical methodologies to enhance clinical trial efficiency.
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