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Statistician Delivery and Device Development - United States  

Lilly (company)

Posted on : 10 April 2017

Project Description

Statistician Delivery and Device Development
United States
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.
Delivery Devices Research and Development (DDR&D) and Indianapolis Device Manufacturing (IDM) are responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling. The Statistician position is responsible for providing statistical support to all functional areas within IDM and DDR&D.

Key Objectives/Deliverables
  • Provide daily statistical support to device development activities, test system qualifications, method validations and transfers, monitoring of manufacturing processes, and manufacturing investigations at component molding and assembly operations.
  • Identify broad technical issues related to device development and manufacturing where statistics can be helpful, drive assessment of options, apply innovative statistical techniques as applicable, and implement robust solutions. Merge scientific thinking and business knowledge to impact decisions.
  • Harmonize statistical approaches across device and parenteral product networks.
  • Develop and administer statistics training courses. Mentor engineers, QA/QC representatives, management, and third parties on developing problem-solving skills, statistical thinking, data analysis techniques, and approaches to continuous improvement.
  • Effectively communicate study results in meetings, presentations, reports and regulatory submissions. Write technical reports, local statistical procedures, and work instructions.
  • Prioritize multiple projects in development and manufacturing across organizational functions and products.
  • Minimum of a MS degree in Statistics or related scientific field with 3 years of experience
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Excellent problem solving skills.
  • Strong interpersonal skills (job requires significant customer/peer/management interaction).
  • Excellent verbal and written communication skills.
  • Ability to participate in and facilitate decision-making.
  • Proficiency in the use of statistical software (eg: JMP, SAS, R, S-Plus, etc.)
  • Technical knowledge in statistics and the ability to apply statistical methods to solve business problems.
  • Ability to write technical reports with statistical content and provide summary presentations of statistical results to management.3-5 years of industry experience using statistics.
  • Trained in Six Sigma methodology.
  • Knowledge of cGMP and ISO requirements as they relate to devices.
  • Experience in device development.
  • Experience using JMP, Minitab, and SAS software
  • Coursework (Design of Experiments, Statistical Process Control, Acceptance Sampling , Engineering)
  • Experience performing Monte Carlo simulations.
  • Shift: Monday–Friday, flex time observed
  • Location: LTC-North, Indianapolis, IN
  • Travel Requirements: 0-10% approx.
  • 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.