Director - Statistics - Lilly Regenerative Medicines

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. At Lilly, we unite caring with discovery to make life better for people around the world. Lilly Regenerative Medicine (LRM) carries out this mission ambitiously, utilizing some of the most cutting-edge science to deliver therapies that address the root cause of disease for patients living with rare diseases and sensory disorders. Our work is driven by a singular commitment: to transform the lives of patients who have had too few options for too long.

Purpose:

The Project Statistician at the Director level provides statistical leadership in multiple dimensions including: Lead the development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level Combine analytical thinking and therapeutic area knowledge to shape internal and external environment to improve the effectiveness of drug development Use strong foundation of statistical experience to enrich decision making, identify efficiencies, and increase the probability of technical success of projects Champion breakthrough approaches to implement innovative statistical methodology and applications Influence team on the critical risks and plan for resolution. Integrate information and make data-driven decisions

Primary Responsibilities:

• Statistical Trial Design and Analysis Provide input on study protocol, design studies and write protocols for the conduct of each study. Be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data sciences in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Perform peer-review of work products from other statistical colleagues.
• Communication of Results and Inferences Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and interact with regulators.
• Therapeutic Area Knowledge Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
• Regulatory Compliance Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
• Statistical leadership and Teamwork Introduce and apply innovative methodology and tools to solve critical problems. Merge 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.

Minimum Qualification/Requirements:

• Ph.D. in Statistics OR Biostatistics 7+ years of experience in clinical research and development in the Pharmaceutical Industry
• 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 (e.g., FDA, EMA)
• Experience in gene therapy, rare disease, and/or ophthalmology clinical development
• Proficient in statistical programming languages/software such as SAS, R, Spotfire, etc
• Interpersonal communication skills for effective customer consultation and collaboration
• Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.
• Self-management skills with a focus on results for 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 (e.g., regulatory submissions)

Other Information/Additional Preferences:

• 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 (e.g., FDA, EMA)
• Experience in gene therapy, rare disease, and/or ophthalmology clinical development
• Proficient in statistical programming languages/software such as SAS, R, Spotfire, etc
• Interpersonal communication skills for effective customer consultation and collaboration
• Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.
• Self-management skills with a focus on results for 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 (e.g., regulatory submissions)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $193,500 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits:

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly