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.

Responsibilities:

• 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.

Requirements:

• 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.

Compensation DOE - $190-260k base salary + benefits