Director - Statistics - Lilly Regenerative Medicine

Lilly • Indianapolis, IN

1d • $193,500 - $308,000

About The Position

The Director-level Project Statistician provides statistical leadership for Lilly Regenerative Medicine programs. The role leads clinical plans, innovative study designs, statistical analyses, and interpretation of results at the program level. It applies statistical expertise and therapeutic-area knowledge to improve drug-development effectiveness, support decision-making, identify efficiencies, increase the likelihood of technical success, and advance innovative statistical methods and applications. The role also identifies critical risks, plans resolutions, and integrates information to support data-driven decisions.

The Project Statistician contributes to study protocols and designs, selects and applies statistical methods, prepares protocol and statistical analysis plan sections, and conducts analyses using reporting databases. The role collaborates on data quality assurance, reviews colleagues’ work, and helps communicate study results through reports, regulatory submissions, manuscripts, presentations, and interactions with regulators. It requires knowledge of disease states, competitive landscapes, and regulatory environments, as well as the ability to lead projects independently and influence cross-functional business decisions.

The position requires a Ph.D. in Statistics or Biostatistics and at least seven years of clinical research and development experience in the pharmaceutical industry. Preferred background includes clinical trials, medical research or real-world evidence; Data Monitoring Committees; regulatory submissions and agency interactions; and gene therapy, rare disease, or ophthalmology development. The anticipated wage is $193,500–$308,000. Full-time equivalent employees are eligible for a company bonus, subject in part to company and individual performance, and eligible employees may participate in a comprehensive benefits program.

Requirements

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

Nice To Haves

• Significant experience with clinical trials, medical research, and/or real-world evidence.
• An 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 the FDA or EMA.
• Experience in gene therapy, rare disease, and/or ophthalmology clinical development.
• Proficiency in statistical programming languages or software such as SAS, R, or Spotfire.
• Interpersonal communication skills for effective customer consultation and collaboration.
• Teamwork and leadership skills, including the 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 for clinical plans, study designs, analyses, and interpretation of results at the program level.
• Provide input on study protocols, design studies, and write protocols for study conduct.
• Select statistical methods for analysis, author the relevant protocol and statistical analysis plan sections, and conduct analyses after creation of a reporting database.
• Collaborate with data sciences on planning and implementing data quality assurance plans.
• Maintain current knowledge of statistical methodology, apply varied and new methods, and justify selected methods.
• Peer-review work products from other statistical colleagues.
• Influence team members regarding appropriate research methods.
• Collaborate with team members to write reports and communicate results.
• Communicate study results through regulatory submissions, manuscripts, oral presentations, one-on-one customer interactions, and scientific meetings.
• Respond to regulatory queries and interact with regulators.
• Use knowledge of disease states, competitive landscapes, and the regulatory environment to strengthen customer focus, collaboration, and scientific contribution.
• Follow applicable corporate, medical, local, and departmental policies, procedures, processes, and training requirements.
• Introduce and apply innovative methodology and tools to solve critical problems.
• Combine scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions.
• Lead projects independently and work effectively across functions.
• Apply technical expertise to influence business decisions.
• Identify critical risks and plan for their resolution; integrate information and make data-driven decisions.

Benefits

• Company bonus for full-time equivalent employees, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as 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