Submission Data Delivery Lead

BioSpace; Indianapolis (IN); On-site; USD 65,000 - 149,000; Full time

Benefits offered by this job

401(k) plan

Comprehensive benefits

Paid time off

Job summary

Lilly is seeking a data/SDnA professional to support submission data delivery and regulatory data standards. You will coordinate submissions, ensure data quality, and collaborate with global teams to advance drug development programs.

Strong knowledge of SDTM/ADaM, SAS, and regulatory guidelines is essential. Responsibilities include process improvement, data governance, and confidentiality compliance in a fast-paced environment with international travel.

Qualifications

• Bachelor’s degree required in a related field.
• Experience with clinical data management and drug development preferred.
• Knowledge of data flow, data quality, and regulatory data standards.

Responsibilities

• Coordinate submissions and plan submission data deliverables.
• Ensure high-quality submission deliverables with regulatory guidance.
• Provide root cause analysis during audits and assessments.
• Improve processes to reduce cycle time and increase efficiency.
• Protect confidential information and ensure privacy compliance.

Skills

SAS

R

CDISC SDTM/ADaM

GCP knowledge

Statistical analysis

Education

Bachelor's degree

Tools

RIM

eCTD

Job description

Lilly is seeking a data/SDnA professional to support submission data delivery and regulatory data standards. You will coordinate submissions, ensure data quality, and collaborate with global teams to advance drug development programs.

Strong knowledge of SDTM/ADaM, SAS, and regulatory guidelines is essential. Responsibilities include process improvement, data governance, and confidentiality compliance in a fast-paced environment with international travel.