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Eli Lilly and CompanyPosted 10/19/2026full-timeRemote • Massachusetts • United StatesLead💰 $193,500 - $308,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical methodologies and clinical research, with a strong focus on regulatory submissions and innovative study designs. Proven ability to lead projects, influence decision-making, and collaborate effectively across functions.
Highest-signal resume keywords
Ph.D. In Statistics Or Biostatistics7+ Years Of Experience In Clinical ResearchProficiency In SAS, R, And SpotfireExperience With IND, BLA, Or NDA SubmissionsStatistical Leadership And Technical Expertise
About the role
Key responsibilities & impact- Lead development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level
- Shape the internal and external drug-development environment using analytical thinking and therapeutic-area knowledge
- Enrich decision-making, identify efficiencies, and increase the probability of project technical success
- Champion innovative statistical methodologies and applications
- Influence teams on critical risks and resolution plans; integrate information and make data-driven decisions
- Provide input on study protocols and design studies
- Write protocols for study conduct
- Select statistical methods for data analysis
- Author protocol and statistical analysis plan sections
- Conduct analyses after creation of the reporting database
- Collaborate with data sciences on data quality assurance plans
- Maintain current statistical methodology knowledge and proficiency with new methods
- Peer-review statistical colleagues’ work products
- Influence team members regarding appropriate research methods
- Collaborate on reports and communicate study results
- Communicate results through regulatory submissions, manuscripts, oral presentations, one-on-one customer interactions, and scientific meetings
- Respond to regulatory queries and interact with regulators
- Understand disease states, competitive landscapes, and regulatory environments
- Perform work in compliance with applicable corporate, medical, local, and departmental policies, procedures, processes, and training
- Introduce and apply innovative methodology and tools to solve critical problems
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions
- Lead projects independently and work effectively across functions
- Apply technical expertise to influence business decisions
Requirements
What you’ll need- Ph.D. in Statistics OR Biostatistics
- 7+ years of experience in clinical research and development in the Pharmaceutical Industry
- Significant experience with clinical trials, medical research, and/or real-world evidence
- Established track record of developing and maintaining an area of statistical or collaborative research
- Experience with Data Monitoring Committees (DMC)
- Experience contributing to IND, BLA, or NDA submissions, including direct interaction with regulatory agencies such as FDA and EMA
- Experience in gene therapy, rare disease, and/or ophthalmology clinical development
- Proficiency in statistical programming languages/software such as SAS, R, and Spotfire
- Interpersonal communication skills for effective customer consultation and collaboration
- Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions
- Self-management skills focused on timely and accurate completion of competing deliverables
- Resource management skills
- Creativity and innovation
- Demonstrated problem-solving ability and critical thinking
- Business process expertise associated with critical activities such as regulatory submissions
Benefits
Comp & perks- Company bonus depending on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups (ERGs)
- Disability accommodation support during the application process
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical AnalysisClinical TrialsStudy DesignData AnalysisStatistical MethodologiesRegulatory SubmissionsData Monitoring CommitteesInnovative MethodologyProblem-SolvingCritical Thinking
Soft Skills
Interpersonal CommunicationTeamworkLeadershipSelf-ManagementCreativity
Industry Keywords
Pharmaceutical IndustryGene TherapyRare DiseaseOphthalmology Clinical DevelopmentReal-World Evidence