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 employees work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism.
We prioritize our work and put people first, seeking individuals committed to making a positive impact worldwide.
Provide strong statistical leadership in the drug development process.
The statistical analyst prepares CDISC-compliant databases, creates statistical summary tables and figures according to schedule, and collaborates with study team members during protocol development, data analysis plans, and regulatory interactions from a statistical perspective.
????/Primary responsibilities Statistical Analysis Results Delivery Collaborate globally to prepare CRT packages meeting regulatory standards.
Select appropriate statistical methods and develop programming code for datasets and outputs.
Work with data management on data quality assurance.
Stay updated on standards, tools, and regulatory requirements.
Manage projects to deliver databases and statistical outputs.
Participate in peer reviews and seek innovative, efficient working methods.
Use Communication Skillsets Coordinate with team members and global partners to deliver results timely.
Manage statistical dataset preparation and presentation of topics such as new tools and methodologies.
Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge Understand disease states and medical assessments to define analysis parameters appropriately.
Regulatory Compliance Ensure all work complies with company policies, procedures, and regulations.
Statistical Leadership and Teamwork Introduce innovative methodologies.
Combine scientific and business insights to solve problems.
Lead projects independently and influence business decisions.
Either:
M.S.
in statistics, biostatistics, or related field, with relevant certifications acceptable.
or
Extensive experience in healthcare as a computational statistician with a science background (biology or epidemiology), including statistical/methodological knowledge, clinical trial and regulatory expertise, and bilingual communication skills in English and Japanese.
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