Senior Director, Biostatistics

We are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.

Your priorities will include:

• As the lead compound 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.
• Rich experience and expertise in the drug development of CNS diseases. Specifically, Alzheimer disease experience is highly desired.
• Strong Statistical technical skills, such as innovatively applying statistical principles, theories, and concepts to clinical study designs, simulations and analyses.
• Deep hands-on operational experiences in Biostatistics deliverables, including but not limited to study design, Statistical Analysis Plans (SAP), and producing or validating statistical outputs, etc.
• Good project and people management skills. 
• Successful experience in managing CRO vendors for timely and quality deliveries.
• Up to date knowledge of industry and regulatory developments in Neuroscience. Rich understanding in the industry and regulatory thinking of Alzheimer’s Disease landscape is a plus.
• 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.

#LI-BL1

#LI-Remote