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 corporate 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.

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.

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.