Associate Director – Data Standards Development

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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$111,000 - $162,800

The Data Standards Developer is accountable for crafting data collection standards, providing technical leadership with respect to internal and industry data standards, and ownership for data standards across the clinical trial data flow.

This position collaborates with Data Standards Implementation Leaders and Data Management roles to deliver data collection standards components for use in global clinical trials across all phases and therapeutic areas.

Portfolio Delivery

• Partner with Data and Analytics colleagues to provide proactive strategic, scientific, and technical input for clinical data standards creation, implementation and governance that enable efficient and regulatory compliant data collection, delivery, integration, normalization and downstream analysis.
• Develop standards to be used and followed at each stage of the clinical trial dataflow, including terminology, data verification standards, and CRF instructions.
• Maintain libraries of data standards accessible to all personnel.
• Ensure facility of data transfer between Lilly and external partners by defining relationships between internal and external standards.
• Influence external standards communities (i.e., CDISC, CDASH) and Data and Analytics colleagues to ensure that clinical data is readily available for study team utilization.

Enterprise Leadership

• Represent the Data and Analysis Standards Team at appropriate internal and external venues.
• Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China.
• Ensure that activities are performed according to established guidelines, standard processes, and in compliance with all laws and regulations.
• A partner in shared learning and process improvements within the organization, including with partners at LCCI.
• Facilitate creation of data standards to accelerate study development and analysis.
• Articulate the value of data standards in terms of reliability, time, cost, quality, and scalability.

Project Management

• Increase speed, accuracy, and consistency in the development, of data standards and associated technical and operational solutions.
• Enable metrics reporting
• Partner with Data and Analytics colleagues, including members of the Study Build Programming Team, to deliver data standards in support of study database builds by first patient visit.
• Influence data standard decisions and strategies for a therapeutic area or business unit.
• Apply therapeutic knowledge and possess a deep understanding of the technology used to create, maintain, and apply data standards.

Basic Qualifications/Requirements

• Bachelor’s degree preferably in life sciences or a health-related field
• Minimum 5 years’ experience in data standards development or data management
• 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.

Additional Skills/Preferences

• Experience with collaborating multi-functionally to deliver results.
• Ability to apply clinical data sciences from data standards and collection through data delivery.
• Working knowledge of external data standards (i.e., CDASH and CDISC) and regulatory requirements for standard data submission.
• Knowledge of clinical concepts and expertise at the indication, compound, or therapeutic area level.
• Ability to translate clinical data strategies into data standards and collection needs.
• Facilitate the lead development of data standards solutions to address clinical development challenges.
• Passionate about improving technological solutions using new technologies.
• Experience with the following:
• Articulating the flow of data (structure and format) from patient to analysis and applying this knowledge to data standards and solutions.
• Clinical Metadata Repository.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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