Director - Statistics (RWE)

BioSpace; Indianapolis (IN); On-site; USD 167,000 - 260,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana is seeking a Clinical Project Statistician to develop protocols, analysis plans, and reporting databases for clinical studies. The role emphasizes leadership in statistical methods, collaboration across teams, and clear communication of results for regulatory submissions and scientific forums.

The position requires a PhD in Statistics or related field with substantial Real World Evidence experience and proficiency in SAS, R, and related tools.

Qualifications

• Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science with at least 7 years of Real World Evidence experience.

Responsibilities

• Design study protocols and statistical analysis plans for clinical studies.
• Select statistical methods and justify analysis approaches.
• Collaborate with data sciences to ensure data quality.
• Communicate results in reports, regulatory submissions, and scientific meetings.

Skills

SAS

R

Spotfire

WinBUGs

Interpersonal communication

Team leadership

Education

Ph.D. in Statistics/Biostatistics/Epidemiology/CS

Tools

SAS

R

Spotfire

WinBUGs

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose

Job Description

The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for clinical studies.

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.

Minimum Qualification Requirements

• Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science with at least 7 years of experience in Real World Evidence research

Other Information/Additional Preferences

• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc
• Interpersonal communication skills for effective customer consultation
• Teamwork and leadership skills
• Technical expertise and application with working knowledge of experimental design and statistical analysis
• 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $166,500 - $259,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.