Director - Statistics

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 work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company focused on solving the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics, and gene-editing, Verve is pioneering a new approach to cardiovascular care through single-course gene editing medicines.

The company’s initial programs – VERVE-101, VERVE-102, and VERVE-201 – target genes validated for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver for treating heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD). VERVE-201 targets the ANGPTL3 gene for homozygous familial hypercholesterolemia (HoFH) and refractory hypercholesterolemia. Verve is headquartered in Boston, Massachusetts.

About the role

The Project Statistician at the Director level provides statistical leadership across multiple dimensions, including technical expertise in multi-disciplinary projects, assessment of new statistical methodologies, development of clinical plans and innovative protocol designs, and consulting on priority clinical projects.

Responsibilities

• Collaborate with study personnel to design studies, write protocols, and provide input on study protocols.
• Select statistical methods for data analysis, author protocol sections and statistical analysis plans, and conduct analyses once a reporting database is created.
• Collaborate with data sciences to plan and implement data quality assurance plans.
• Maintain currency with statistical methodology and proficiency in applying new methods.
• Influence team members regarding appropriate research methods and perform peer-review of statistical work products.
• Collaborate with team members to write reports and communicate results via regulatory submissions, manuscripts, or presentations.
• Respond to regulatory queries and interact with regulators.
• Understand disease states, competitive landscapes, and the regulatory environment to enhance customer focus and scientific contribution.
• Perform work in full compliance with corporate, medical, local, and departmental policies and procedures.
• Introduce and apply innovative methodology to solve critical problems, merging scientific thinking with business knowledge.
• Lead projects independently and work effectively across functions, applying technical expertise to influence business decisions.

Requirements

• Ph.D. in Statistics or Biostatistics.
• At least 7 years of proven experience in clinical research and development.
• Significant experience with clinical trials, medical research, and/or real-world evidence.
• Technical expertise in experimental design and statistical analysis.
• Established track record of developing and maintaining statistical or collaborative research.
• Proficiency in statistical programming languages/software such as SAS, R, Spotfire, or WinBUG.
• Demonstrated problem-solving ability and critical thinking.
• Teamwork and leadership skills, with the ability to provide statistical leadership and technical expertise.
• Strong interpersonal communication skills for effective customer consultation and collaboration.
• Creativity, innovation, and business process expertise (e.g., regulatory submissions).

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits and 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).

Pay

The anticipated wage for this position is $193,500 - $338,800. Full-time equivalent employees are also eligible for a company bonus, depending on company and individual performance.