Director – Statistics

🕒 October 19

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $193.5k - $308k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level • Shape the internal and external drug-development environment using analytical thinking and therapeutic-area knowledge • Enrich decision-making, identify efficiencies, and increase the probability of project technical success • Champion innovative statistical methodologies and applications • Influence teams on critical risks and resolution plans; integrate information and make data-driven decisions • Provide input on study protocols and design studies • Write protocols for study conduct • Select statistical methods for data analysis • Author protocol and statistical analysis plan sections • Conduct analyses after creation of the reporting database • Collaborate with data sciences on data quality assurance plans • Maintain current statistical methodology knowledge and proficiency with new methods • Peer-review statistical colleagues’ work products • Influence team members regarding appropriate research methods • Collaborate on reports and communicate study results • Communicate results through regulatory submissions, manuscripts, oral presentations, one-on-one customer interactions, and scientific meetings • Respond to regulatory queries and interact with regulators • Understand disease states, competitive landscapes, and regulatory environments • Perform work in compliance with 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

🎯 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 • 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 FDA and EMA • Experience in gene therapy, rare disease, and/or ophthalmology clinical development • Proficiency in statistical programming languages/software such as SAS, R, and Spotfire • 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 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

🏖️ Benefits

• Company bonus depending on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups (ERGs) • Disability accommodation support during the application process

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