Sr. Advisor - Statistics

Biopharma Careers; Indianapolis (IN); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Lilly in Indianapolis, Indiana, seeks a Sr. Advisor - Statistics to develop protocol designs and data analysis plans in collaboration with clinicians and scientists. The role focuses on statistical trial design, analysis, and communication of results for regulatory submissions.

The position emphasizes maintaining up-to-date statistical methods, performing peer reviews, and ensuring compliance with corporate and regulatory standards.

Qualifications

• Develop protocol designs and data analysis plans.
• Collaborate with physicians and scientists to interpret results.
• Operate in compliance with policies, training, and regulatory requirements.

Responsibilities

• Statistical trial design and analysis for clinical studies.
• Prepare and communicate study results via reports, manuscripts, or presentations.
• Support regulatory submissions and respond to regulatory inquiries.

Skills

Statistical analysis

Study design

Regulatory submissions

Regulatory compliance

Data quality assurance

Communication

Job description

# Sr. Advisor - StatisticsIndianapolis, Indiana, United States of America FULL\\_TIMENotify me about similar jobsView Full Job & Apply at LillyLilly is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt 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:**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.## Job detailsSeniorityNot listedFunctionNot listedTherapeutic areaNot listedLocationIndianapolis, Indiana, United States of AmericaEmployment typeFULL\\_TIME