Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description A growing East-Coast biotech at a pivotal stage of development is seeking an Associate Director or Director of Biostatistics to lead a critical Phase III trial. • Report directly to the SVP of Biometrics and serve as the lead biostatistician for a complex Phase III trial. • Author the statistical sections of the protocol and develop the Statistical Analysis Plan (SAP). • Oversee all in-house statistical and programming efforts related to the study, ensuring data integrity and alignment with regulatory standards. • Lead the trial through regulatory submission and interact with health authorities as needed. • Responsibility for vendor oversight and coordination of internal data management and programming functions. • Ensure all standard Director-level biostatistics responsibilities are fulfilled, with a focus on Phase III and regulatory readiness. Qualifications • PhD in Biostatistics or a related field or Masters with supplementary experience. • At least 7 years of experience in the industry, with significant exposure to Phase III trials. • Strong background in regulatory submissions and health authority interactions. • Exceptional communication skills and flexibility in therapeutic areas. • East Coast remote location preferred. Requirements • Compensation DOE - $190-260k base salary + benefits Apply tot his job