Company OverviewAt 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.
ResponsibilitiesThe Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.
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 conducting the actual analysis once a reporting database is created.
- Collaborate with data management in the planning and implementation of data quality assurance plans.
- Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
- Participate in peer-review 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 to interact with regulators.
- Therapeutic Area Knowledge
- Understand disease states 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.
- Introduces and applies innovative methodology and tools to solve critical problems
- Merges scientific thinking & business knowledge to identify & impact business issues.
- Drives projects internally (or externally), and works effectively across functions. Uses technical expertise to influence business decisions.
- Identifies broad technical issues, drives assessment of options and implements robust solutions.
- Has broad understanding of regulatory environment; demonstrates leadership on regulatory issues.
- Ph.D in Statistics or Biostatistics
- Interpersonal communication skills for effective customer consultation
- Teamwork and leadership skills
- Technical growth and application with working knowledge of experimental design and statistics
- 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 strategic thinking
- Business process expertise associated with critical activities (e.g. regulatory submissions)
- Strong written and verbal communication skills: at least one manuscript submitted to or published in a peer-reviewed journal AND at least one oral presentation at a statistical conference
- Proficiency in statistical software (SAS OR R)
Additional InformationLilly 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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 55490.
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.
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