Sr. Advisor - Statistics (RWE)

BioSpace; Indianapolis (IN); On-site; USD 151,500 - 244,200; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Prescription drug benefits

Flexible benefits

Life insurance

well-being benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a Clinical Project Statistician to develop and analyze protocol designs, plans, and reporting databases for clinical studies. You will work with physicians, researchers, and teams to ensure robust statistical methods and compliant reporting.

The role emphasizes collaboration, regulatory communication, and leadership in applying modern statistical approaches to Real World Evidence within a global healthcare setting.

Qualifications

• Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science is required.
• 3+ years of Real World Evidence (RWE) research experience preferred.
• Proficiency in statistical programming languages/software (SAS, R, Spotfire, WinBUGs).
• Strong interpersonal and collaboration skills for cross-functional teams.
• Ability to lead projects and influence decisions across functions.

Responsibilities

• Design study protocols and statistical plans for clinical studies.
• Select statistical methods and write statistical analysis plans and reports.
• Collaborate with data sciences on data quality and analysis.
• Communicate study results to stakeholders and regulators.
• Lead projects and apply innovative methods across the team.

Skills

SAS

R

Spotfire

WinBUGs

Regulatory knowledge

Communication

Team leadership

Education

Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science

Tools

SAS

R

Spotfire

WinBUGs

Job description

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.

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

The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.

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.

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 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). Learn more about all of our groups.

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

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical benefits
• eligibility for dental benefits
• eligibility for vision benefits
• eligibility for 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)

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