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Lead Statistician - Chorus

Employer
Lilly
Location
Indianapolis, Indiana
Salary
Competitive
Closing date
Jun 28, 2019

View more

Discipline
Life Sciences
Position Type
Full Time
Job Type
Other
Organization Type
All Industry, Pharma

Job Details

The purpose of the job is to collaborate with Chorus scientific staff in the development of clinical plans, protocol designs, data analysis plans and critical success factors for Phase I-II clinical trials. The Chorus Statistician is the primary statistical expert for all Chorus projects, and may support projects directly 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:
  1. Statistics and Data Management
  • Provide support on the development of clinical plans, innovative protocol designs and study objectives, and statistical analysis plans in collaboration with Chorus scientific staff.
  • Understand disease states and trial design options to make strong scientific and strategic contributions to clinical 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.
  • Respond to regulatory queries and to interact with regulators.
  • 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.
  1. Chorus Clinical Trial Registry
  • Review Chorus CTR submissions for accuracy, completeness, and compliance.
  • 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.
  • Insure accuracy and completion of required CTR Statistics Deliverables according to timing specifications.
  1. Chorus Data Steward
  • Provide consultation to clinical trial data management process and data/reporting standards.
  • Advise Chorus teams on resolve data issues.
  1. Chorus Line Management
  • Recruit, manage, develop, train, oversee and retain personnel to assist with the development and implementation of the Chorus Group initiatives.
  • Provide management and mentoring of Chorus direct reports.
  • Provide leadership and consultation to Lilly external search individuals, corporate business development individuals, and PFC activities.
  • Assure regulatory compliance for all Chorus operations.


Company Overview

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.

Basic Qualifications

  • Education: M.S., Ph.D
  • Industry experience: 7+ years of experience in pharmaceutical and/or health care industry.


Additional Information

  • International and domestic travel may be required.
  • Core work hours, Monday-Friday.
  • 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.


Additional Skills/Preferences

  • 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.
  • Proficient in the SAS programming language.
  • Resource management skills and experience in working with third party providers.
  • Business process expertise associated with critical activities (e.g. regulatory submissions).
  • Field of Study: Statistics, Biostatistics
  • Deep 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 in various therapeutic areas, including oncology, diabetes, neurosciences, CV, or autoimmune.

Company

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.

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