Principal Research Scientist - Statistics (Remote)

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 39,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked diligently to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.

Purpose:

The Project Statistician at the Principal Research Scientist level provides statistical leadership in multiple dimensions including:

• Provides technical leadership and expertise in initiating and executing multi-disciplinary or cross functional projects that impact the Lilly Research Laboratory and the Statistical Sciences organization;

• Leads the assessment and introduction of new statistical technology and methodology to apply to broader practice;

• Leads the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and/or medical colleagues;

• Provides consulting and statistical direction on priority clinical projects.

Key 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

• Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.

• Assist in or 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.

• Influence team members regarding appropriate research methods

• Perform peer-review of work products from other statistical colleagues.

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.

Basic Qualifications:

• Ph.D. in Statistics OR Biostatistics

• At least 7 years of proven experience in clinical research and development

Additional Skills/Preferences:

• Significant experience with clinical trials, medical research, and/or real-world evidence

• Technical expertise and application with working knowledge of experimental design and statistical analysis

• An established track record of developing and maintaining an area of statistical or collaborative research

• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc

• Demonstrated problem solving ability and critical thinking

• Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions.

• Interpersonal communication skills for effective customer consultation and collaboration

• Creativity and innovation

• Business process expertise associated with critical activities (e.g. regulatory submissions)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ~~~ ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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!

#WeAreLilly