Director - Statistics - Lilly Regenerative Medicine

Eli Lilly and Company • Us, MA

7d • $193,500 - $308,000

About The Position

The Director-level Project Statistician provides statistical leadership for clinical development programs at Lilly Regenerative Medicine. The role leads development of clinical plans, innovative study designs, statistical analyses, and interpretation of results. It applies statistical expertise and therapeutic-area knowledge to improve drug development, enrich decision-making, identify efficiencies, increase the probability of technical success, and influence project risk planning. The statistician integrates information to make data-driven decisions and champions innovative statistical methodologies and applications.

The role contributes to study protocols and design, selects and applies statistical methods, authors protocol and statistical analysis plan sections, and conducts analyses once reporting databases are available. It collaborates with data sciences on data-quality plans, maintains current methodological expertise, reviews colleagues’ work, and influences appropriate research methods. The statistician works with team members to report and communicate findings, including through regulatory submissions, manuscripts, presentations, and interactions with regulators and customers.

The position requires understanding disease states, competitive landscapes, and the regulatory environment, and performing work in compliance with applicable corporate, medical, local, and departmental policies and training. It also involves independent project leadership and cross-functional collaboration, applying technical expertise to influence business decisions, and combining scientific thinking with business knowledge to identify issues and implement solutions.

Requirements

• Ph.D. in Statistics or Biostatistics.
• At least 7 years of experience in clinical research and development in the pharmaceutical industry.

Nice To Haves

• Significant experience with clinical trials, medical research, and/or real-world evidence.
• Established track record of developing and maintaining an area of statistical or collaborative research.
• Experience with Data Monitoring Committees (DMC).
• Experience contributing to IND, BLA, or NDA submissions, including direct interaction with regulatory agencies such as FDA or EMA.
• Experience in gene therapy, rare disease, and/or ophthalmology clinical development.
• Proficiency with statistical programming languages or software such as SAS, R, and Spotfire.
• Interpersonal communication skills for effective customer consultation and collaboration.
• Teamwork and leadership skills, including ability to provide statistical leadership and technical expertise to influence business decisions.
• Self-management skills focused on timely and accurate completion of competing deliverables.
• Resource management skills.
• Creativity and innovation.
• Demonstrated problem-solving ability and critical thinking.
• Business process expertise associated with critical activities such as regulatory submissions.

Responsibilities

• Provide statistical leadership in clinical plans, study design, statistical analysis, and interpretation of results at the program level.
• Contribute to study protocols, design studies, and write protocols for their conduct.
• Select statistical methods; author statistical sections of protocols and statistical analysis plans; and conduct analyses after reporting databases are created.
• Collaborate with data sciences to plan and implement data-quality assurance plans.
• Maintain current knowledge of statistical methodology and proficiency in applying and justifying methods.
• Peer-review work products from statistical colleagues and influence team members on appropriate research methods.
• Collaborate with team members to write reports and communicate study results.
• Communicate study results through regulatory submissions, manuscripts, oral presentations, customer discussions, and scientific meetings.
• Respond to regulatory queries and interact with regulators.
• Apply knowledge of disease states, competitive landscapes, and the regulatory environment to support customer focus and collaboration.
• Perform work in compliance with assigned curricula and applicable corporate, medical, local, and departmental policies, procedures, processes, and training.
• Introduce and apply innovative methodology and tools to solve critical problems.
• Lead projects independently and work effectively across functions.
• Use technical expertise and business knowledge to identify issues, evaluate options, implement solutions, and influence business decisions.
• Influence teams on critical risks and plans for resolution.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree