Senior Director, Statistical Methodologist
BiogenSalary not specified
Full Time
Senior (5 to 8 years)
Executive Director - Product Development Statistics at Eli Lilly and Company
Indianapolis, Indiana, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries
Requirements
- Highly qualified statistical leader with strong technical skills in statistics
- Strong desire and ability to take initiative, educate, and communicate the value of good statistical practices to scientific partners (biologists, chemists, formulators, engineers)
- Experience in experimental design and analysis for chemists/biologists, formulation scientists, and analytical chemists
- Knowledge of developing/optimizing chemical/biochemical processes, oral/parenteral formulations, batch/continuous manufacturing
- Expertise in analytical method development, validation, transfer, and stability studies (long-term/accelerated)
- Ability to develop/implement novel methods/strategies (modeling, experimental design, process control, multivariate analysis, Bayesian methods, quality by design)
- Skills in authoring/reviewing CMC regulatory submission documents
- Capability to collaborate on applied research projects and communicate results clearly (visualization, manuscripts, presentations)
Responsibilities
- Provide strategic and statistical leadership to all assets in the product development portfolio
- Supervise, coach, mentor staff for excellence; manage performance, career development, recruiting, hiring, onboarding
- Direct staff on departmental policies, organizational goals, performance management, company policies; ensure training
- Develop proactive leadership at all levels; retain top talent; manage performance for corporate/functional success
- Provide statistical leadership/coaching at strategic/tactical levels; oversee portfolio support, resource allocation
- Communicate/collaborate with scientific partners (Regulatory, Discovery, Development, Manufacturing, Medical, GPS)
- Ensure compliance with internal/external standards, SOPs; maintain Lilly values work environment
- Lead experimental design/analysis for process/formulation development, analytical methods, stability studies
- Author/review CMC regulatory sections for global product approvals
- Collaborate on applied research (modeling, etc.); communicate results via meetings, presentations, manuscripts
- Perform work in full compliance with regulatory requirements
Skills
Statistics
Statistical Leadership
People Management
Career Development
Performance Management
Recruiting
Scientific Collaboration
Nonclinical Statistics
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees