Director – Statistics

🕒 Outubro 19

💵 $193.500 - $308.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Eli Lilly and Company

Eli Lilly and Company

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• Lead development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level • Use statistical experience and therapeutic-area knowledge to improve drug-development effectiveness • Enrich decision-making, identify efficiencies, and increase the probability of technical success • Champion breakthrough statistical methodology and applications • Influence teams on critical risks and plans for resolution • Integrate information and make data-driven decisions • Provide input on study protocols, design studies, and write protocols • Select statistical methods, author protocol and statistical analysis plan sections, and conduct analyses after database creation • Collaborate with data sciences on data quality assurance plans • Maintain statistical methodology currency and justify selected 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, 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 policies, procedures, processes, and training • Introduce 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

🎯 Requisitos

• 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, such as regulatory submissions

🏖️ Benefícios

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including 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, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups (ERGs)

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