An East-Coast clinical-stage Biopharma is seeking an accomplished Director of Biostatistics to lead their statistical efforts. Reporting to the Head of Biometrics.

Responsibilities:

• Oversee statistical strategies and ensure integrity and compliance across clinical trials.
• Lead the design of clinical studies and analysis of clinical data.
• Work closely with cross-functional teams in Clinical Operations, Development, and Regulatory Affairs.
• Mentor and guide a team of biostatisticians, programmers and data managers, ensuring best practices and high-quality deliverables.
• Supporting the Head of Biometrics, represent the biostatistics function in high-level project decisions and regulatory interactions.
• Oversee CRO deliverables and ensure alignment with organizational goals.

Requirements:

• Advanced degree (PhD or Master’s with supplementary experience) in Biostatistics or a related field.
• 10+ years of experience in the life sciences industry, including significant experience with Phase III
• Experienced in regulatory submission activities – NDA, BLA, etc.
• Strong project leadership and communication skills, with the ability to translate complex statistical concepts for non-statistical stakeholders.

Compensation DOE - $220-260k base salary + benefits