Submission Data Delivery Lead

BioSpace; Indianapolis (IN); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health and well-being benefits

Job summary

Lilly is seeking a qualified professional to support SDnA data submission data delivery and analytics. This role focuses on coordinating submission data deliverables, ensuring alignment with the compound’s data strategy, and leveraging data standards to meet regulatory expectations.

Applicants should have clinical data management experience and a strong background in SDTM/ADaM, SAS, R, and regulatory knowledge.

Qualifications

• Degree in a relevant field; experience in clinical data management preferred
• Familiarity with SDTM and ADaM data standards
• Experience with RIM and eCTD is a plus

Responsibilities

• Coordinate submission data deliverables and ensure alignment with data strategy.
• Provide solution consultation for SDnA processes using data standards and regulatory guidance.
• Monitor data quality and perform testing to ensure deliverables meet regulatory requirements.
• Build partnerships across teams and track process metrics.
• Identify opportunities to improve data processes and reduce cycle times

Skills

CDISC SDTM/ADaM

Clinical data management

Regulatory knowledge

Data analysis

Education

Bachelor’s degree

Tools

SAS

R

R-Studio

SQL

Job description

Lilly is seeking a qualified professional to support SDnA data submission data delivery and analytics. This role focuses on coordinating submission data deliverables, ensuring alignment with the compound’s data strategy, and leveraging data standards to meet regulatory expectations.

Applicants should have clinical data management experience and a strong background in SDTM/ADaM, SAS, R, and regulatory knowledge.