Director - Statistics

BioSpace; Boston (MA); On-site; USD 194,000 - 339,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave

Well-being benefits

Job summary

Lilly in Boston seeks a lead statistician to shape design and analysis across Verve gene-editing programs. You will guide study protocols, SAPs, data quality, and regulatory communication, collaborating with physicians and cross-functional teams.

Ideal candidates hold a PhD in Statistics or Biostatistics with 7+ years in clinical research, expertise in SAS/R/Spotfire/WinBUG, and a track record of statistical leadership in regulatory submissions and scientific publications.

Qualifications

• Ph.D. in Statistics or Biostatistics is required.
• At least 7 years of proven experience in clinical research and development.
• Proficient in SAS, R, Spotfire, WinBUG, and related statistical software.

Responsibilities

• Lead statistical trial design and analysis for multi-disciplinary projects.
• Collaborate with physicians and medical colleagues to develop protocols and SAPs.
• Communicate study results in regulatory submissions, manuscripts, and presentations.
• Provide statistical direction and consulting across priority clinical projects.

Skills

Statistical leadership

Clinical research experience

Team leadership

Interpersonal communication

Education

PhD in Statistics or Biostatistics

7+ years clinical R&D experience

Tools

SAS

R

Spotfire

WinBUG

Job description

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

• 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.

Key Responsibilities

The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.

Statistical Trial Design and Analysis

• 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.

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.

Basic Qualifications

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

Additional Skills/Preferences

• 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)

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$193,500 - $338,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• company-sponsored 401(k) eligibility
• 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.

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