Associate Director Biostatistician

Overview

• Lead biometrics function across late-phase cardiovascular drug development programs, ensuring statistical integrity and precision medicine strategies.
• Collaborate with cross-functional teams to design clinical studies, select endpoints, and develop regulatory submission strategies.
• Oversee statistical analysis plans, ensuring alignment with clinical and regulatory requirements.
• Provide statistical expertise for data monitoring committees and case report form designs.
• Manage CROs to deliver high-quality analysis outputs and interpret results effectively.
• Contribute to publications, including manuscripts, posters, and presentations, advancing scientific discoveries.
• Mentor junior statisticians, fostering professional growth and development within the team.
• Drive process improvement efforts for Biostatistics and cross-functional collaborations.
• Ensure compliance with regulatory standards and best practices in statistical methodologies.

Key Responsibilities & Duties

• Collaborate with clinical, regulatory, and medical affairs teams to integrate project strategies.
• Author and review statistical sections of clinical protocols and study reports.
• Develop and oversee statistical analysis plans and data visualization methods.
• Provide statistical input to data monitoring committee charters and case report form designs.
• Manage statistical activities for regulatory submissions, addressing agency questions effectively.
• Support preparation of scientific publications, ensuring high-quality outputs.
• Lead standardization and process improvement initiatives within Biostatistics.
• Mentor and guide junior statisticians, promoting team development.
• Ensure adherence to 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.
• Expertise in advanced statistical methodologies and regulatory alignment.
• Proficiency 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.