Associate Director Of Biostatistics

Associate Director of Biostatistics Overview

• The Associate Director of Biostatistics will lead statistical initiatives supporting drug development activities across Phase I-IV studies.
• Collaborate with cross-functional teams to design studies, select innovative statistical methods, and interpret clinical trial results.
• Provide strategic input into clinical development plans, ensuring alignment with regulatory standards and requirements.
• Contribute to the preparation of regulatory submissions, including briefing books and integrated summary documents.
• Operate within a hybrid work model, balancing on-site and remote work to optimize productivity and collaboration.
• Join a dynamic environment focused on innovation in neuroscience and drug development methodologies.
• Enhance your career by engaging with high-performing teams and contributing to impactful clinical research.

Associate Director of Biostatistics Key Responsibilities & Duties

• Lead a team of Clinical Biostatisticians to meet regulatory, scientific, and business objectives.
• Collaborate with senior members across functional areas for strategic planning of clinical development.
• Design and analyze clinical studies using advanced statistical methodologies.
• Provide oversight for statistical content in regulatory interactions and submissions.
• Coordinate statistical efforts with external organizations, CROs, and consultants.
• Implement emerging methodologies to enhance clinical development practices.
• Develop and maintain department SOPs to ensure compliance and efficiency.
• Monitor vendor performance and program deliverables to meet timelines and quality standards.
• Participate in planning and preparation for regulatory submissions, ensuring statistical integrity.

Associate Director of Biostatistics Job Requirements

• Ph.D. in Statistics or Biostatistics with 16+ years of clinical research experience.
• Expertise in neuroscience and methodologies for clinical trials and lifecycle management.
• Proven experience interacting with regulatory agencies in the U.S. and internationally.
• Strong analytical skills with a demonstrated ability to interpret and analyze clinical data.
• Excellent communication skills, capable of conveying statistical concepts to non-specialists.
• Flexibility to adapt to changing priorities and work effectively under pressure.
• Experience in managing cross-functional teams and fostering collaboration.
• Willingness to travel domestically and internationally up to 15% of the time.