Associate Director Of Biostatistics

Job DetailExperience Level Associate DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference 0000022022Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful biostatistical strategies in a dynamic hybrid work environment. Collaborate with cross-functional teams to drive innovation in neuroscience research. Enhance your career with strategic regulatory contributions.Job DescriptionAssociate Director of Biostatistics OverviewThe 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 & DutiesLead 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 RequirementsPh.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.