Job details
Job type full-time
Full job description
At lilly, we unite caring with discovery to make life better for people around the worldWe are a global healthcare leader headquartered in indianapolis, indianaOur 35,000 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 volunteerismWe give our best effort to our work, and we put people firstWe’re looking for people who are determined to make life better for people around the world.
Organization overview:
At lilly, we serve an extraordinary purposeFor more than 140 years, we have worked diligently to discover medicines that make life betterThese 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 positionThe 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 functionsApply technical expertise to influence business decisions.
Basic qualifications:
Ph.dIn 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.gRegulatory 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 jobsIf you require an accommodation to submit a resume for positions at lilly, please email lilly human resources ( lilly_recruiting_compliance@lists.lilly.com ) for further assistancePlease note this email address is intended for use only to request an accommodation as part of the application processAny 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.
As a condition of employment with eli lilly and company in the united states and puerto rico, you must be fully covid-19 vaccinated and provide valid proof of vaccination to the company.
