Associate Director Biostatistician

Overview

• Lead statistical strategies for late-phase drug development, ensuring compliance with regulatory standards and advancing therapeutic innovations.
• Collaborate with interdisciplinary teams to design clinical studies and develop impactful endpoints for cardiovascular therapies.
• Drive statistical analysis plans and oversee data interpretation for regulatory submissions and scientific publications.
• Provide expertise to data monitoring committees, optimizing case report form designs and statistical methodologies.
• Manage external partners to ensure high-quality statistical outputs and actionable insights.
• Mentor and develop junior statisticians, fostering a culture of growth and excellence within the team.
• Champion process improvements and innovation in statistical practices and methodologies.
• Ensure alignment with industry best practices and regulatory requirements, driving impactful contributions to the field.

Key Responsibilities & Duties

• Collaborate with clinical and regulatory teams to integrate statistical strategies into project plans and submissions.
• Author and review statistical sections of protocols, reports, and regulatory documentation.
• Develop and oversee statistical analysis plans, ensuring precision and adherence to standards.
• Provide statistical input to data monitoring committees and optimize case report forms for clinical studies.
• Lead statistical activities for regulatory submissions, addressing inquiries and ensuring compliance.
• Support scientific publication efforts, contributing impactful insights to the field of biostatistics.
• Drive standardization and process improvements within statistical functions and methodologies.
• Mentor junior statisticians, promoting professional development and team excellence.
• Ensure compliance with regulatory standards and industry best practices in all statistical activities.

Job Requirements

• PhD in Statistics, Biostatistics, or related field with 7+ years of experience, or MS with 10+ years.
• Proficiency in advanced statistical methodologies and regulatory alignment for drug development.
• Expertise in statistical software (SAS, R, Python) and data visualization techniques.
• Experience managing CROs and collaborating with cross-functional teams in a dynamic environment.
• Knowledge of cardiovascular drug development and digital health data preferred.
• Strong communication skills for conveying statistical concepts to diverse audiences effectively.
• Experience with regulatory submissions (NDAs, MAAs) highly desired.
• Demonstrated ability to work independently and lead statistical initiatives successfully.
• Commitment to compliance with regulatory standards and best practices in biostatistics.