[Hiring] Director of Statistics @Lilly

Role Description

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.

Primary Responsibilities

• Statistical Trial Design and Analysis:
  • 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.
• 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 regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
• Regulatory Compliance:
  • 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.
• 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.

Qualifications

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

Requirements

• 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.
• Experience with Data Monitoring Committees (DMC).
• Experience contributing to IND, BLA, or NDA submissions, including direct interaction with regulatory agencies (e.g., FDA, EMA).
• Experience in gene therapy, rare disease, and/or ophthalmology clinical development.
• 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).

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).