Executive Director - Product Development Statistics

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.

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.

Minimum Qualification Requirements

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

Additional Skills/Preferences:

• 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

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

$177,000 - $308,000

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).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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