Job Title: Executive Director – Product Development Statistics
Location: Indianapolis, Indiana, United States
Category: Research & Development / Biostatistics
Job Type: Full-Time, Regular
Job ID: R-96350
Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, committed to advancing patient care through innovative medicines and robust scientific collaboration. Our product development teams work across chemistry, biology, formulation, and engineering disciplines to ensure high-quality pharmaceutical products from discovery to commercialization.
Role Overview:
The Executive Director – Product Development Statistics will provide strategic and statistical leadership for the product development statistics team. This role ensures the application of advanced statistical methods across experimental design, process optimization, and analytical development, while coaching and mentoring team members to drive excellence in pharmaceutical product development.
Key Responsibilities:
1. Leadership & Team Development:
Lead, coach, and mentor the product development statistics team to achieve departmental goals.
Oversee employee career development, performance management, recruitment, onboarding, and training.
Foster a culture of statistical rigor, scientific collaboration, and compliance with company policies.
2. Statistical Strategy & Implementation:
Provide strategic guidance and statistical leadership for all product development assets.
Collaborate with biologists, chemists, formulators, engineers, and regulatory teams to design, execute, and analyze experiments.
Apply advanced statistical methods, including experimental design, Bayesian methods, process modeling, and multivariate analysis.
Guide statistical support for analytical method development, validation, transfer, and stability studies.
Contribute to novel statistical methods to advance drug development and manufacturing processes.
3. Communication & Scientific Collaboration:
Translate complex statistical results into clear, actionable insights for cross-functional teams.
Present findings in team meetings, scientific forums, regulatory submissions, and publications.
Partner with internal and external stakeholders to communicate study outcomes effectively.
4. Regulatory Compliance:
Ensure statistical work aligns with regulatory requirements and internal SOPs.
Author or review statistical sections in CMC regulatory submission documents globally.
Maintain compliance with internal policies, external standards, and industry best practices.
Minimum Qualifications:
Ph.D. in Statistics, Biostatistics, or Industrial Engineering.
Minimum 15 years of pharmaceutical experience in product development statistics.
U.S. work authorization for full-time employment.
Preferred Qualifications:
At least 5 years of management or leadership experience in pharmaceutical statistics.
Proven experience managing large portfolios and cross-functional teams.
Deep expertise in experimental design, Bayesian methods, quality by design, and statistical applications in pharmaceutical development.
Strong strategic thinking, problem-solving, and results-oriented skills.
Proficiency in R and JMP statistical software.
Excellent communication, collaboration, negotiation, and leadership skills.
Compensation & Benefits:
Salary range: $177,000 – $308,000, based on experience, skills, and location.
Eligible for company bonus based on individual and company performance.
Comprehensive benefits: 401(k), pension, medical, dental, vision, flexible spending accounts, life insurance, paid time off, wellness programs, and employee engagement initiatives.
Equal Opportunity & Inclusion:
Lilly is an EEO employer and does not discriminate based on age, race, color, religion, gender identity, sex, sexual orientation, gender expression, genetic information, ancestry, national origin, veteran status, disability, or any other legally protected status.
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