Senior Director Of Biostatistics

Job DetailExperience Level Sr DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference 0000019123Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Drive biostatistical strategies for impactful clinical development phases I-IV. Collaborate on innovative trial designs and regulatory compliance initiatives. Lead transformative methodologies in a dynamic, hybrid work environment.Job DescriptionSenior Director Of Biostatistics OverviewLead 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 & DutiesDesign 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 RequirementsPh.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.