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Our client is a clinical-stage biopharma company focusing in the areas of Neurology, Rare Diseases, and Neurodegenerative Disorders. They are currently seeking a highly skilled and experienced Senior Director of Biostatistics to be responsible for managing and delivering project goals effectively, ensuring compliance and timely execution of statistical strategies for global clinical trials. In this role you will have 2 direct reports (both Director level) and full responsibility for a very important study now in Phase III and moving into submission. Extremely competitive compensation package.

Key Responsibilities:

• Define the statistical strategy for assigned projects, applying appropriate methodologies to study designs and data analyses throughout all phases of clinical trials (Phase I-IV).
• Provide expert statistical input and consultancy for global clinical trials and translational medicine research.
• Ensure rigorous statistical and scientific decision-making throughout the project lifecycle.
• Collaborate with internal and external stakeholders on study design, analysis, reporting, and communication of clinical trial results.
• Author and review critical documents including briefing documents, protocols, Statistical Analysis Plans (SAP), and clinical study reports (CSR).
• Support project and clinical study teams with go/no-go criteria, summary reports, and results interpretation.
• Participate in regulatory interactions, including IND/CTA filings and safety reporting.

Requirements:

• Ph.D. in Statistics or a related discipline with 10+ years of experience, or MS with 15+ years of experience in the biotechnology industry.
• Proven interaction and submission experience with FDA and EMA regulatory bodies.
• Expertise in project and people management, particularly in developing Neuroscience or Rare Disease programs is a must.
• In-depth knowledge of life cycle management and a consistent track record of applying statistical principles to achieve regulatory approvals.
• Extensive hands-on experience with Biostatistics deliverables, including study design, protocol development, and statistical analysis plans.
• Up-to-date knowledge of industry and academic developments in Neuroscience, with the ability to apply this knowledge to clinical study design and analysis.
• Demonstrated flexibility and innovative problem-solving capabilities in a dynamic environment.
• Strong leadership, project management, collaboration, communication, and organizational skills.
• Advanced programming skills in SAS, R, and other relevant statistical software.
• Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling techniques.