Clinical Trials Data Delivery Lead for Submissions

Eli Lilly and Company; Indianapolis (IN); Hybrid; USD 117,000 - 172,000; Full time

Benefits offered by this job

Relocation package

Comprehensive benefits

Job summary

Eli Lilly and Company is seeking an Associate Director- Submission Data Delivery in Indianapolis, IN, to lead global data consistency and submission processes. The role requires extensive data management, SDTM/ADaM expertise, and collaboration with cross-functional teams in a hybrid setup (3 days onsite/2 days remote).

Ideal candidates have 5+ years in clinical data, a scientific degree, and strong knowledge of regulatory expectations (FDA/PMDA). A relocation package may be offered.

Qualifications

• Bachelor’s degree ideally in a scientific area.
• Minimum 5 years of clinical trial data experience in drug development in areas intersecting (e.g. clinical operations, statistics, information technology, health outcomes, regulatory, etc.).
• Candidates must be legally authorized to work in the United States; no visa sponsorship expected.
• Preferred: SDTM/ADaM, PK/PD, and other data; experience with data submission processes; strong project management and influencing skills; knowledge of FDA/PMDA expectations and RIM.

Responsibilities

• Provide technical leadership and process ownership for Statistics, Data and Analytics.
• Act as main contact for development and support of process and technology.
• Communicate global data strategy related to process/technology; influence regulatory and business issues.
• Oversee submission data packages for SDTM, ADaM, PK/PD, and other data.
• Liaise with product/study teams, regulatory and vendors throughout submission and post-submission data requests.

Skills

Clinical data

Data management

SDTM/ADaM

Regulatory

R

Python

SAS

Project management

Leadership without authority

Education

Bachelor’s degree (scientific)

Tools

R

Python

SAS

Pinnacle 21

Job description

Eli Lilly and Company is seeking an Associate Director- Submission Data Delivery in Indianapolis, IN, to lead global data consistency and submission processes. The role requires extensive data management, SDTM/ADaM expertise, and collaboration with cross-functional teams in a hybrid setup (3 days onsite/2 days remote).

Ideal candidates have 5+ years in clinical data, a scientific degree, and strong knowledge of regulatory expectations (FDA/PMDA). A relocation package may be offered.