Eli Lilly and Company · 7 hours ago
Associate Director - Data Standards
Indianapolis, IN
Full-time
Onsite
Lead/Staff, Director/Executive
$116K/yr - $187K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Associate Director - Data Standards will partner with Data and Analytics colleagues to create, implement, and govern clinical data standards, ensuring compliance and efficiency in data collection and analysis.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
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
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
Qualification
Required
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
Preferred
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 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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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