Executive Director - Product Development Statistics

Eli Lilly and Company•Indianapolis, IN

40d

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. We are looking for a highly qualified statistical leader who will lead the product development statistics team in supporting a wide variety of projects in the product development (nonclinical) area of LRL in collaboration with biologists, chemists, formulators, and engineers. In addition to strong technical skills, the role requires a strong desire and ability to take initiative, educate, and communicate the value of good statistical practices and concepts to a variety of scientific partners. Purpose The Executive Director will provide strategic and statistical leadership to all assets in the product development portfolio and will provide overall leadership including supervision, career development, and performance management for the product development statistics team.

Requirements

Ph.D. in Statistics, Biostatistics, or Industrial Engineering with at least 15 years pharmaceutical experience

Nice To Haves

At least 5 years of management or leadership experience.
Proven leadership in managing a large portfolio and people.
Deep knowledge in one or more research disciplines in statistics, for example experimental design, Bayesian methods.
Deep understanding of applying statistical methods to the development of pharmaceutical products
Strong strategic thinking and problem-solving abilities, attention to detail, and result oriented behaviors in a fast-paced environment.
Excellent communication, teamwork, and negotiation skills for effective customer collaboration
Proficient in R and JMP

Responsibilities

People Leadership Responsible for coaching and mentoring staff for excellence
Accountable for overall performance of direct reports
Responsible for directing employee career development.
Provide leadership and direction to staff regarding departmental policies, organizational goals, objectives, performance management, and company policies
Ensure staff members receive appropriate training to perform their jobs.
Responsible for recruiting, hiring, and effectively onboarding and integrating new staff.
Develop, Implement, and Manage Statistical Leadership Ensure proactive leadership development at all levels
Accountable for developing and retaining top talent and managing performance to ensure corporate and functional success.
Provide statistical leadership and coaching at both a strategic and tactical level.
Oversee management of product portfolio support including assignment and allocation of Statistics resources
Communicate and collaborate with partners from scientific areas, including Regulatory, Discovery, Development, and Manufacturing, Medical, Global Patient Safety (GPS), etc.
Ensure compliance with internal and external standards and SOPs.
Maintain a work environment that upholds the Lilly values.
Statistical Activities Experimental design and analysis for chemists/biologists and formulation scientists to develop & optimize chemical/biochemical processes as well as oral and parenteral formulations, in both batch and continuous manufacturing
Experimental design and analysis support for analytical chemists to develop, validate, and transfer analytical methods
Design and analysis of long-term and accelerated stability studies to advise development of clinical phase and commercial specifications and expiry dating
Develop and implement novel methods and strategies to enable or advance drug development and manufacturing
Author/review sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for successful product approval throughout the world
Collaborate with scientists and statisticians on applied research projects related to modeling, experimental design, process control, multivariate analysis, Bayesian methods, quality by design, and more.
Communication of Results Collaborate with team members or external partners to communicate development study results with an emphasis on clarity and visualization
Assist with or be responsible for communicating via manuscript or oral presentation
Communicate results in one-on-one and team meetings with scientists, leaders, or external partners, and present at scientific meetings
Regulatory Compliance Perform work in full compliance with assigned curricula and follow applicable Corporate, local, and departmental policies, procedures, processes, and training.

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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