Sr. Advisor - Statistics (RWE)

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 152,000 - 244,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation

Health benefits

Flexible benefits

Life insurance

Time off

Well-being programs

Job summary

Eli Lilly and Company is seeking a Clinical Project Statistician to design studies, analyze data, and report results in collaboration with physicians and research teams. You will lead methodological choices, ensure data quality, and communicate findings for regulatory submissions and scientific meetings.

Responsibilities include protocol input, statistical analysis planning, and cross-functional coordination to advance clinical studies while maintaining regulatory compliance and scientific rigor.

Qualifications

• Ph.D. in Statistics/Biostatistics/Epidemiology/CS with 3+ years in Real World Evidence research.
• Proficient in SAS, R, Spotfire, WinBUGs or similar.
• Strong communication for customer consultation.
• Teamwork and leadership skills.
• Working knowledge of experimental design and statistical analysis.
• Self-management with timely delivery of deliverables.
• Resource management skills.
• Creativity and innovation.
• Demonstrated problem solving and critical thinking.

Responsibilities

• Design studies and write protocols for conduct of each study; select statistical methods.
• Collaborate with data sciences on data quality assurance and methodology.
• Communicate results via regulatory submissions, manuscripts, or presentations.
• Understand disease areas, regulatory environments to inform analysis.
• Ensure compliance with corporate and departmental policies.

Skills

Interpersonal skills

Team leadership

Statistical methods

Self-management

Resource management

Creativity

Problem solving

Education

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

Tools

SAS

R

Spotfire

WinBUGs

Job description

Purpose

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 3 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.

Employee Resource Groups

• Africa


• Middle East, Central Asia Network


• Black Employees at Lilly


• Chinese Culture Network


• Japanese International Leadership Network (JILN)


• Lilly India Network


• Organization of Latinx at Lilly (OLA)


• PRIDE (LGBTQ+ Allies)


• Veterans Leadership Network (VLN)


• Women’s Initiative for Leading at Lilly (WILL)


• enAble (for people with disabilities)

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• 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)

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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!