Data Submissions Lead — SDnA & Process Improvement

Information Technology Senior Management Forum

Indianapolis (IN)

On-site

USD 65,000 - 149,000

Full time

14 days+

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Benefits offered by this job

Company bonus

401(k) and benefits

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a Statistics, Data, and Analytics (SDnA) professional to coordinate submission data deliverables and provide data-driven solutions across regulatory processes. The role focuses on ensuring high-quality data submissions, alignment with data strategy, and collaboration with cross-functional teams in a global environment.

The position emphasizes governance, data standards, and adherence to CFR 21 Part 11, ICH, and GCP requirements, with

Qualifications

Bachelor's degree required; authorized to work in the United States full-time.
Experience with clinical data management and drug development is highly preferred.
Knowledge of regulatory expectations (ICH, GCP) is beneficial.

Responsibilities

Coordinate submission data deliverables to align with data strategy (Data Definition Documents, XPTs).
Provide data expertise to ensure high-quality submission deliverables and regulatory guidance adherence.
Identify customer needs related to process and technology performance and enhancements.
Monitor and test deliverables for quality and compliance.
Maintain standardized business processes and effective communication across teams.