Senior Director Of Biostatistics Overview • Lead biostatistical strategies for clinical development phases I-IV, ensuring innovative methodologies and regulatory compliance. • Collaborate with cross-functional teams to optimize clinical development plans aligned with organizational objectives. • Provide strategic input into clinical trial design, statistical analysis, and interpretation of study results. • Oversee statistical content for regulatory submissions and interactions with global agencies. • Coordinate statistical endeavors with external organizations, CROs, and consultants. • Implement emerging methodologies and innovative approaches in clinical development. • Contribute to the development of departmental SOPs and best practices. • Maintain a hybrid work environment with flexible on-site and remote arrangements. Senior Director Of Biostatistics Key Responsibilities & Duties • Design and analyze clinical studies using advanced statistical methods to support drug development. • Provide oversight for statistical content in regulatory interactions and submissions. • Collaborate with senior members across functional areas for strategic planning. • Coordinate statistical activities with external organizations, including CROs and consultants. • Identify and implement innovative methodologies for clinical development. • Participate in the establishment of departmental SOPs and operational standards. • Oversee vendors to ensure program deliverables and timelines are met. • Contribute to planning and preparation of regulatory submissions and integrated summary documents. Senior 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. • Extensive experience with regulatory agency interactions, both US and international. • Strong analytical skills for data interpretation and analysis in drug development. • Excellent communication skills to convey statistical information to diverse audiences. • Ability to adapt to changing priorities and work effectively under pressure. • Willingness to educate internal teams on statistical methodologies. • Domestic and international travel up to 15% as required.