Director - Statistics

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

About the Role

The Project Statistician at the Director level provides statistical leadership in multiple dimensions:

• Lead the development of clinical plans, innovative study designs, statistical analysis, and interpretation of results at the program level
• Combine analytical thinking and therapeutic area knowledge to shape internal and external environments to improve the effectiveness of drug development
• Use a strong foundation of statistical experience to enrich decision-making, identify efficiencies, and increase the probability of technical success of projects
• Champion breakthrough approaches to implement innovative statistical methodology and applications
• Influence the team on critical risks and plan for resolution; integrate information and make data-driven decisions

Responsibilities

Statistical Trial Design and Analysis

• Provide input on study protocols, design studies, and write protocols for the conduct of each study
• Be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created
• Collaborate with data sciences in the planning and implementation of data quality assurance plans
• Maintain currency with respect to statistical methodology, proficiency in applying new and varied methods, and competency in justifying methods selected
• Perform peer-review of work products from other statistical colleagues
• Influence team members regarding appropriate research methods

Communication of Results and Inferences

• Collaborate with team members to write reports and communicate results
• Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings
• Respond to regulatory queries and interact with regulators

Therapeutic Area Knowledge

• Understand disease states, competitive landscapes, and the regulatory environment to enhance customer focus and collaboration and be seen as a strong scientific contributor

Regulatory Compliance

• Perform work in full compliance with assigned curriculum(s) and follow applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training

Statistical Leadership and Teamwork

• 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

• Ph.D. in Statistics or Biostatistics
• At least 7 years of experience in clinical research and development in the Pharmaceutical Industry

Skills

• Significant experience with clinical trials, medical research, and/or real-world evidence
• An established track record of developing and maintaining an area of statistical or collaborative research
• Proficient in statistical programming languages/software such as SAS, R, Spotfire, etc.
• 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 with a focus on results for 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 (e.g., regulatory submissions)

Pay

The anticipated wage for this position is $177,000 - $308,000. Full-time equivalent employees are also eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits
• Eligibility to participate in a company-sponsored 401(k) and pension
• Vacation benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)