Associate Director - Data Standards

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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.

• 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.
• 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 maintenance 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.

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.

• 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…