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Advisor/Sr. Advisor - Clinical Biostatistics

Employer
Eli Lilly and Company
Location
Remote, Indiana
Start date
Apr 16, 2024

View more

Discipline
Clinical, Clinical Research, Science/R&D, Biostatistics
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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.

Position Summary

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.

Key Responsibilities:

  • 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.

Basic Qualifications:
  • 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.

Additional Skills/Preferences:
  • 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).

Additional Information:
  • Lilly currently anticipates that the base salary for this position could range from between $138,000 to $222,200 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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