Lilly Statistician -Chorus in Indianapolis, Indiana
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.
The purpose of the job is to collaborate with Chorus colleagues and customers in the development and delivery of protocols, analysis plans, and data analyses for Phase I-II clinical trials. The Chorus Statistician is the primary statistical leader for assigned Chorus clinical trials and may support projects directly, in partnership with the lead statistician, or supervise statistical vendors to do so. The Chorus statistician will oversee the clinical trial database, data analysis, statistical sections of study reports and regulatory documents, and disclosure of data to the Clinical Trial Registry. The statistician will support the Chorus mission of innovative lean-to-POC clinical development and collaboration with external R&D partners.
CORE JOB TASKS :
Statistics and Data Management:
Provide ad hoc statistical analyses.
Provide support for the development of innovative protocol designs and study objectives, and statistical analysis plans.
Maintain proficiency in statistical sciences and work, lead the assessment and introduction of new statistical technology and methodology, and promote and apply innovative methods in Chorus.
Be accountable for selection of statistical methodology, conduct of data analysis, and statistical sections of protocols, study reports and regulatory documents.
Collaborate with team members to communicate results via regulatory submissions, manuscripts, oral presentations in group settings, and at scientific meetings.
Contribute to the selection of external network of vendors for statistical support, provide statistical oversights on external vendor deliverables to ensure high-quality project delivery.
Collaborate with clinical operations personnel in the planning and implementation of data quality assurance plans.
Maintain professional connection with Lilly Statistics including shared learning, peer review, and consultation as needed.
Perform work in full compliance with assigned curriculum(s) and follow all applicable Corporate, Medical and Chorus departmental policies, procedures, and processes.
Chorus Clinical Trial Registry:
Advise Chorus teams on pertinent planning aspects of CTR submissions, including protocol writing, statistical analysis planning, final study reports, data collection and compilation, and compliance issues.
Deliver and/or review CTR submissions to ensure they are accurate, complete, compliant, and timely.
Chorus Data Steward:
Provide consultation to clinical trial data management process and data/reporting standards.
Advise Chorus teams on resolving data issues.
M.S. in Statistics, Biostatistics, or equivalent.
Industry experience: 3+ years of experience in pharmaceutical and/or health care industry.
Proficient in the SAS programming language.
Interpersonal communication, teamwork, and situational leadership skills.
Technical expertise, problem solving, creativity and strategic thinking skills with regard to experimental designs and statistics.
Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
Knowledge of the drug development process, especially early phase drug development (phase I-II).
Experience in modeling and simulation, adaptive designs, and Bayesian statistics.
Experience with FACTS, R, JMP Clinical, Spotfire, and other statistical software.
Knowledge in various therapeutic areas, including oncology, diabetes, neurodegeneration, pain, or immunology.
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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!
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