Director - Statistics

Lilly•Indianapolis, IN

About The Position

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 around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Purpose: The Project Statistician at the Director level provides statistical leadership in multiple dimensions including: 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 environment to improve the effectiveness of drug development Use 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 team on the critical risks and plan for resolution. Integrate information and make data-driven decisions

Requirements

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

Nice To Haves

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)

Responsibilities

Provide input on study protocol, 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, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
Perform peer-review of work products from other statistical colleagues.
Influence team members regarding appropriate research methods
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.
Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Perform work in full compliance with assigned curriculum(s) and will be responsible for following 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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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