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About Prevail Therapeutics
Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is focused on developing novel gene therapies for Parkinson’s disease and other genetically defined neurodegenerative diseases. Prevail is based in New York city at the Alexandria Center for Life Sciences.
We are seeking an experienced and highly motivated Advisor (Senior Manager)/Senior Advisor (Associate Director) Clinical Biostatistics to provide statistical leadership and work as a study statistician across our programs. The position title will be commensurate with expertise and experience. Applicant may be office based in New York City area or remote with previously demonstrated capability. The position reports to the Director of Clinical Biostatistics.
- Provide statistical leadership and work as a study statistician within Prevail clinical programs
- Oversight, management, and collaboration with project teams on all statistical related aspects of assigned programs and/or projects. Includes management and oversight of Contract Research Organization Biostatistical and Programming activities, including managing timelines, quality, and budgets.
- Provide scientifically rigorous statistical input into clinical development plans, study protocols, statistical analysis plans, technical statistical programming specifications, clinical study reports, and regulatory submissions and queries. Expert interpretation of statistical analysis results and other support initiatives.
- Represents biostatistics in meetings with regulatory authorities, independent data monitoring committees, or key opinion leaders/advisors as required.
- Develop statistical programs as necessary to perform analyses, prepare data displays and verify the correctness of data and analyses.
- Effective and courteous communication of project planning and status, and statistical analyses and interpretation in a cross-functional setting. Attendance and participation at study team meetings.
- Review and provide statistical input to data management documents to ensure appropriate data capture and quality for analysis.
- Ensure regulatory compliance of statistical analyses with SOPs, FDA/EMA and ICH guidelines, and other applicable regulations/guidelines. Participate in regulatory and CRO/vendor audits for programs and projects.
- Manage competing priorities across multiple studies. Work independently and exercise appropriate judgement.
- PhD with minimum 6 years of work experience, or Masters with minimum of 8 years of experience in biostatistics related field is required.
- At least 6-years of the work experience must be in biotech/Pharmaceutical/CRO industry clinical development across all phases of research.
- Experience in the design, analysis, and reporting of clinical trials
- Prior IND/BLA/NDA submission and regulatory interaction experience is strongly preferred
- Experience in neurodegeneration, rare diseases, gene therapy and/or genetic medicine is preferred
- Proficient SAS programming skills and understanding of CDISC models and standards. Programming skills with R are a plus but not required.
- Strong oral and written communication skills. Able to function effectively in an individual and team environment.
- Ability and willingness to travel up to 15% of the time, including domestic and international travel (depending on applicant location).
- Lilly currently anticipates that the base salary for this position could range from between $130,500 to $211,200 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).