Senior Director Biostatistics

Your priorities will include:

• As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.
• Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.
• Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.
• Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.
• Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.
• Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.
• Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.
• Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).

We'd love to hear from you if you have:

• Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.
• Successful project and people management and expertise in the development of CNS diseases.
• Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.
• Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.
• Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.
• Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.
• Demonstrated strong leadership, project management, collaboration, communication, and organization skills.
• Advanced programming skills in SAS, R and other relevant statistical software solutions.
• Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.
• Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.