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.