Associate Director - Data Standards

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Responsibilities

1. 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. 
This includes participation in or leadership of therapeutic area standards development activities. 
• Actively participate in and influence external standards communities (i.e., CDISC, CDASH) and partner with Data and Analytics colleagues to ensure clinical data standards are readily available for study team utilization. 
• Act accountably for influencing and delivering on project decisions related to clinical data standards operations, including integrated resourcing and technology recommendations. 
• Ensure that strong linkages exist between clinical data standards, study design, downstream data delivery, analysis, and submission. 
• Support efficiency and continuous improvement efforts within the Data and Analysis Standards organization, including the monitoring of standards compliance and maintaining of process controls. 

2. Enterprise Leadership 
• Represent the Data and Analysis Standards team at appropriate internal and external venues. 
• Participate in standards-related governance activities/committees. 
• Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China. 
• Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations. 
• Seek and monitor continuous improvement of key performance metrics related to standards implementation.

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

Basic Qualifications:

Master’s degree in a medical field, informatics, life sciences, health information administration, information technology, nursing, or pharmacy with 3 years of experience or bachelor’s degree with 5 or more years of experience in clinical drug development with expertise in data standards, data science, or areas intersecting with clinical data management.

Additional Skills and Preferences:

• Proven ability to lead development of creative data standards solutions to address clinical development challenges. • Passionate about improving technological solutions using new technologies.

• Experience with setting and implementing strategies and plans to improve complex drug development

processes and capabilities.

• Demonstrated ability to effectively partner/influence cross functionally to deliver results.

• Demonstrated ability to understand and 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

and standards for data submissions.

• Experience effectively working with virtual teams.

• 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.

• Working knowledge of CDISC and evolving data and analysis industry standards and practices.

• Experience with the following:

• Articulating the flow of data (structure and format) from clinical trial participant to analysis and applying this knowledge to data standards and solutions.

• Technology platforms (system/database) for data acquisition and aggregation.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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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