Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to rapidly deliver precision-based therapies to improve the lives of patients and their families.
We are seeking an outstanding senior Biostatistician to join our Clinical Development team and expertly lead statistical strategy, methods, operations, and analyses across all phases of development. The energetic, collaborative, dynamic leader will work closely with the Clinical Development team, including Medical Sciences, Clinical Operations, and Regulatory functions to plan, implement, and analyze clinical studies. This role reports to the VP of Clinical Development Operations.
Key Responsibilities:
- Lead Biostatistician for assigned projects to 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, statistical programming components, 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).
- Identify and manage appropriate statistical consultants/vendors to assist with clinical programs.
Qualifications:
- Ph.D. in Statistics or related discipline with 10+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.
- Deep experience and expertise in the drug development of CNS diseases. Specifically, Alzheimer disease experience and rare disease experience are 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.
- Fully up on industry and regulatory developments in Neuroscience and prepared to integrate them into planning, pivoting, and overall execution.
- Rich understanding of the industry and regulatory thinking of Alzheimer’s Disease landscape and rare disease innovative strategy are a statistically meaningful 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.
- Advanced understanding of the development, programming, management, validation, and documentation maintenance of all programming tasks.
- Extensive knowledge of GCP, ICH guidelines, CDISC standards/implementation guidelines, 21 CFR Part 11, familiarity with EMA/CHMP regulations and guidelines, and other regulatory requirements.
- 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.
This is a hybrid role located at our headquarters in Watertown, MA.
Principals only. No recruiters.
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