Role Summary
Associate Director - Data Standards at Lilly. Lead the development, governance, and delivery of clinical data standards across therapeutic areas, enabling regulatory-compliant data collection, delivery, integration, normalization, and downstream analysis. Partner with Data and Analytics colleagues and external standards communities to drive adoption of standards and ensure alignment with study design and submission requirements.
Responsibilities
- Portfolio Delivery: provide proactive strategic, scientific, and technical input for clinical data standards creation, implementation, and governance.
- Lead or participate in therapeutic area standards development activities and influence external standards communities (e.g., CDISC, CDASH) to ensure standards are available for study teams.
- Influence project decisions related to clinical data standards operations, including resourcing and technology recommendations; ensure linkages between standards, study design, data delivery, analysis, and submission.
- Support continuous improvement within Data and Analysis Standards, monitor compliance, and maintain process controls.
- Enterprise Leadership: represent the Data and Analysis Standards team at internal and external venues; participate in governance activities/committees; maintain awareness of regulatory requirements (US, EU, Japan, China).
- Compliance: ensure activities follow established guidelines, best practices, and all laws and regulations; monitor key performance metrics related to standards implementation.
- Project Management: increase speed and accuracy of data standards development and governance; enable metrics reporting for timelines, accuracy, and reuse; deliver data standards to support study database builds by first patient visit; influence data standards decisions for a therapeutic area or business unit.
Qualifications
- 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+ years of experience in clinical drug development with expertise in data standards, data science, or related areas.
- Preferred: Proven ability to lead development of creative data standards solutions to address clinical development challenges; passion for improving technological solutions using new technologies; experience setting and implementing strategies to improve complex drug development processes and capabilities; ability to partner cross-functionally to deliver results; understanding of clinical data sciences and how data standards support data delivery; working knowledge of external data standards (CDASH/CDISC) and regulatory requirements; experience with virtual teams; knowledge of clinical concepts at the indication/compound/therapeutic area level; ability to translate clinical data strategies into data standards and collection needs; working knowledge of CDISC and evolving industry standards; ability to articulate data flow from trial participant to analysis and apply to data standards; experience with technology platforms for data acquisition and aggregation.
Education
- 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+ years of experience in clinical drug development with expertise in data standards, data science, or related areas.
Additional Requirements
- None beyond stated qualifications.