Overview
Clinical Project Statistician role at Eli Lilly and Company. Lilly is a global healthcare leader focused on discovering and bringing life-changing medicines to patients. Lilly Cork offers a premium campus with hybrid working, benefits, and a commitment to diversity, equity and inclusion (DEI).
Purpose: As a Clinical Statistician, you will be a leader in clinical development programs. You will understand patient and business needs and develop protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and medical colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and to analyze data for clinical studies.
Primary Responsibilities
The job requirements at the time of preparation may change; consult with supervision for actual responsibilities and duties.
* Statistical Trial Design and Analysis: Collaborate with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study; assist in selecting statistical methods for data analysis, author sections of the protocol and statistical analysis plan, and perform analyses once a reporting database is created; collaborate with data sciences to plan and implement data quality assurance; maintain currency with statistical methodologies and justify methods; perform peer-review of work products; influence team members on appropriate research methods.
* Communication of Results and Inferences: Collaborate to write reports and communicate results; assist with regulatory submissions, manuscripts, or oral presentations, and communicate with key customers and present at scientific meetings; respond to regulatory queries and interact with regulators.
* Therapeutic Area Knowledge: Understand disease states, competitive landscapes, and regulatory environment to enhance customer focus and collaboration and be a strong scientific contributor.
* Regulatory Compliance: Perform work in accordance with applicable policies and training; follow corporate, medical, local and departmental procedures.
* Statistical Leadership and Teamwork: Introduce innovative methodology and tools; merge scientific thinking and business knowledge to identify issues and implement solutions; lead projects independently and influence business decisions across functions.
* Minimum Qualification Requirements: M.S. or Ph.D. in Statistics or Biostatistics.
* Other Information/Additional Preferences: Proficiency in SAS, R, Spotfire, WinBUG, or similar; strong interpersonal communication for customer consultation; teamwork and leadership skills; strong technical expertise in experimental design and statistical analysis; self-management and ability to deliver timely results; resource management; creativity and problem solving; familiarity with regulatory submissions.
Equal Employment Opportunity
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodation during the application process. To request accommodation, complete the accommodation request form. Lilly does not discriminate on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLillyUKandIreland
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr