Director of Statistics - Clinical Trials & Innovation

Eli Lilly and Company; Indiana; On-site; USD 194,000 - 308,000; Full time

Benefits offered by this job

Company bonus

401(k)

Medical benefits

Dental benefits

Vision benefits

Vacation benefits

Life insurance

Job summary

Lilly Regenerative Medicine seeks a PhD-level statistician to lead statistical trial design and analyses across programs. You will steer study protocols, SAPs, and regulatory communications, collaborating across data science, clinical, and regulatory teams to optimize drug development in rare diseases and ophthalmology.

Candidates bring extensive experience with DMCs, IND/BLA/NDA interactions, and innovative methodologies to enhance decision-making and technical success.

Qualifications

• Ph.D. in Statistics or Biostatistics, or equivalent.
• 7+ years of experience in clinical research and development in the pharmaceutical industry.
• Significant experience with clinical trials, medical research, or real-world evidence.
• Experience with Data Monitoring Committees (DMC).
• Experience contributing to IND, BLA, or NDA submissions including interaction with regulators (FDA/EMA).
• Experience in gene therapy, rare disease, or ophthalmology development.
• Proficient in SAS, R, Spotfire, or equivalent statistical software.
• Excellent communication and leadership skills with cross-functional teams.

Responsibilities

• Lead development of clinical plans, study designs, statistical analyses, and interpretation at program level.
• Select statistical methods for data analysis and author SAPs; perform analyses.
• Collaborate with data sciences to ensure data quality and methodological rigor.
• Stay current with statistical methodologies and justify methods chosen.
• Peer-review work from statistics colleagues and influence team research methods.
• Communicate study results via regulatory submissions, manuscripts, or presentations.

Skills

Interpersonal communication

Team leadership

Strategic thinking

Creative problem solving

Self-management

Resource management

Critical thinking

Education

PhD in Statistics or Biostatistics

Tools

SAS

R

Spotfire

Job description

Lilly Regenerative Medicine seeks a PhD-level statistician to lead statistical trial design and analyses across programs. You will steer study protocols, SAPs, and regulatory communications, collaborating across data science, clinical, and regulatory teams to optimize drug development in rare diseases and ophthalmology.

Candidates bring extensive experience with DMCs, IND/BLA/NDA interactions, and innovative methodologies to enhance decision-making and technical success.