Director - Statistics

Lilly•Boston, MA

About The Position

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. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve 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 the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets 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 and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts. Purpose: The Project Statistician at the Director level provides statistical leadership in multiple dimensions including: Provides technical leadership and expertise in initiating and implementing multi-disciplinary or cross functional projects that impact the Verve Gene-editing program and Lilly Research Laboratory, Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice, Leads the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues, Provides consulting and statistical direction on priority clinical projects.

Requirements

Ph.D. in Statistics OR Biostatistics
At least 7 years of proven experience in clinical research and development

Nice To Haves

Significant experience with clinical trials, medical research, and/or real-world evidence
Technical expertise and application with working knowledge of experimental design and statistical analysis
An established track record of developing and maintaining an area of statistical or collaborative research
Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc
Demonstrated problem solving ability and critical thinking
Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.
Interpersonal communication skills for effective customer consultation and collaboration
Creativity and innovation
Business process expertise associated with critical activities (e.g. regulatory submissions)

Responsibilities

Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
Assist in or 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.
Influence team members regarding appropriate research methods
Perform peer-review of work products from other statistical colleagues.
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.
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.
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.
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.

Benefits

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).

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