Associate Director, Clinical Data Submission & Delivery

Regulatory Jobs; Indianapolis (IN); Hybrid; USD 117,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical/dental/vision benefits

Flexible benefits

Life insurance

Well-being program

Job summary

Lilly in Indianapolis seeks an Associate Director-Submission Data Delivery to lead global data consistency for regulatory submissions. The role requires deep expertise in data collection, standards, SDTM/ADaM, and collaboration across statistics, data and analytics, regulatory, and study teams.

You will drive process and technology strategy, oversee SDTM/ADaM data packages, and ensure accurate, timely deliverables for complex trials.

Qualifications

• Bachelor’s degree required in a scientific field.
• 5+ years of clinical trial data experience in drug development.
• Authorized to work in the United States; no visa sponsorship expected.

Responsibilities

• Provide technical leadership and process ownership for Statistics, Data and Analytics.
• Liaise with product and study teams, submission teams, across departments.
• Communicate global data strategy relating to process and technology; resolve complex regulatory issues.
• Oversee submission data packages for SDTM, ADaM, PK/PD and others.
• Identify and resolve regulatory and business data process issues.

Skills

SDTM

ADaM

PK/PD

R

Python

SAS

Pinnacle 21

XML

Regulatory knowledge

Education

Bachelor’s degree in a scientific area

Tools

Pinnacle 21

Job description

Lilly in Indianapolis seeks an Associate Director-Submission Data Delivery to lead global data consistency for regulatory submissions. The role requires deep expertise in data collection, standards, SDTM/ADaM, and collaboration across statistics, data and analytics, regulatory, and study teams.

You will drive process and technology strategy, oversee SDTM/ADaM data packages, and ensure accurate, timely deliverables for complex trials.