Associate Director Biostatistician

Overview

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

Key Responsibilities & Duties

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

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.
• Expertise in statistical software (SAS, R, Python) and data visualization techniques.
• Experience managing CROs and collaborating with cross-functional teams.
• Knowledge of cardiovascular drug development and digital health data preferred.
• Strong communication skills for conveying statistical concepts to diverse audiences.
• Experience with regulatory submissions (NDAs, MAAs) highly desired.
• Demonstrated ability to work independently in a dynamic environment.
• Commitment to compliance with regulatory standards and best practices.