Senior Biostatistics Executive
2 weeks ago
Vigil Neuroscience, Inc. is pioneering the development of microglia-focused therapeutics aimed at addressing both rare and prevalent neurodegenerative disorders. Our mission is to enhance the functionality of microglia, the brain's immune system cells, to improve patient outcomes and support their families.
We are in search of an exceptional Senior Biostatistician to join our Clinical Development team. This role will be instrumental in guiding statistical strategy, methodologies, operations, and analyses throughout all stages of clinical development. The ideal candidate will be a dynamic and collaborative leader, working closely with various teams, including Medical Sciences, Clinical Operations, and Regulatory Affairs, to design, implement, and evaluate clinical studies. This position reports directly to the VP of Clinical Development Operations.
Key Responsibilities:- Act as the Lead Biostatistician for designated projects, ensuring effective and timely management of project objectives and responsibilities.
- Establish the statistical strategy and guarantee the application of suitable statistical methodologies in study designs and data analyses for clinical trials.
- Provide expert statistical guidance and consultancy for global clinical trials spanning Phase I to IV, as well as lifecycle management and translational medicine research.
- Ensure rigorous statistical and scientific decision-making processes are upheld.
- Collaborate with both internal and external partners in the design, analysis, reporting, interpretation, and communication of clinical trial findings.
- Author and review essential documents, including protocols, Statistical Analysis Plans (SAP), top-line reports, and integrated summaries.
- Support project and clinical study teams in developing go/no-go criteria, summary reports, and interpreting results.
- Engage in interactions with regulatory bodies, including IND/CTA filings and safety reporting.
- Identify and oversee statistical consultants/vendors to support clinical programs.
- Ph.D. in Statistics or a related field with over 10 years of demonstrated experience in the biotechnology sector, including interactions with regulatory agencies.
- Extensive experience in drug development for CNS diseases, particularly in Alzheimer’s and rare diseases.
- Strong technical statistical skills, with the ability to apply statistical principles innovatively to clinical study designs and analyses.
- Hands-on experience in Biostatistics deliverables, including study design and validation of statistical outputs.
- Proficient project and people management abilities.
- Successful track record in managing CRO vendors to ensure timely and quality deliverables.
- Up-to-date knowledge of industry and regulatory developments in Neuroscience.
- Deep understanding of the Alzheimer’s Disease landscape and innovative strategies for rare diseases.
- Demonstrated ability to adapt and problem-solve in a fast-paced environment.
- Strong leadership, collaboration, communication, and organizational skills.
- Advanced programming skills in SAS, R, and other relevant statistical software.
- Comprehensive knowledge of GCP, ICH guidelines, CDISC standards, and regulatory requirements.
- In-depth understanding of adaptive designs, Bayesian methodology, and complex modeling.
- Exceptional problem-solving skills and the ability to respond promptly to critical tasks.
This position is hybrid, requiring in-office attendance a few days a week.
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