Role Summary
Executive Director - Product Development Statistics: Lead the product development statistics team supporting nonclinical projects in collaboration with biologists, chemists, formulators, and engineers. Provide strategic and statistical leadership, initiative, and the ability to communicate the value of statistical practices to scientific partners.
Responsibilities
- Provide strategic and statistical leadership to all assets in the product development portfolio; oversee supervision, career development, and performance management for the product development statistics team.
- Coach and mentor staff; ensure overall performance of direct reports; manage staff recruitment, onboarding, training, and career development.
- Lead statistical leadership development, retain top talent, and manage performance to ensure corporate and functional success.
- Provide statistical leadership at strategic and tactical levels; oversee allocation of Statistics resources for product portfolio support.
- Collaborate with Regulatory, Discovery, Development, Manufacturing, Medical, GPS, and other partners; ensure compliance with internal/external standards and SOPs; uphold Lilly values.
- Lead experimental design and analysis for chemistry, biology, formulation, analytical chemistry, and related areas; support long-term/accelerated stability studies and regulatory submissions.
- Develop and implement novel methods to advance drug development and manufacturing; contribute to CMC regulatory submission documents; collaborate on applied research projects (modeling, design, process control, multivariate analysis, Bayesian methods, quality by design).
- Communicate results clearly through manuscripts, presentations, and meetings; present at scientific meetings as needed.
- Perform work in compliance with corporate, local, and departmental policies, procedures, and training.
Qualifications
- Minimum: Ph.D. in Statistics, Biostatistics, or Industrial Engineering with at least 15 years of pharmaceutical experience.
- At least 5 years of management or leadership experience; proven leadership in managing a large portfolio and people.
Skills
- Deep knowledge in statistics, including experimental design and Bayesian methods; strong understanding of applying statistical methods to pharmaceutical product development.
- Strategic thinking, problem-solving, attention to detail, and results-oriented in a fast-paced environment.
- Excellent communication, teamwork, and negotiation skills for effective collaboration with customers.
- Proficient in R and JMP.
Education
- Ph.D. in Statistics, Biostatistics, or Industrial Engineering (required).
Additional Requirements
- Travel: Not specified in source.
- Physical demands: Not specified as essential in source.