Data Submissions Lead

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 149,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking candidates for a role within the Statistics, Data, and Analytics (SDnA) department. This position focuses on coordinating data submissions, ensuring data quality, and aligning with regulatory guidance across teams.

Ideal applicants have clinical data management experience, SAS/R skills, and knowledge of CDISC standards. Opportunities include partnering with global PK/PD, regulatory, and CROs to drive submission success.

Qualifications

• Bachelor’s degree is required.
• Authorized to work in the United States on a full-time basis; sponsorship not provided.
• Experience in clinical data management and/or drug development is highly preferred.
• Knowledge of CDISC standards (SDTM/ADaM) and data standards is important.
• Strong written and verbal communication, collaboration, and leadership skills.

Responsibilities

• Submission Data Delivery (70%): coordinate submissions and data deliverables to align with the compound's data strategy.
• Process Management & Communication (15%): build partnerships, track metrics, and provide root-cause analysis.
• Process Improvement (10%): drive efficiency, reduce cycle time, and support cross-functional initiatives.
• Asset Protection (5%): protect confidential information and ensure policy compliance.

Skills

SAS/R skills

CDISC SDTM/ADaM

Data management

Regulatory knowledge

Communication skills

Education

Bachelor's degree

Tools

eCTD

RIM

Job description

Lilly, headquartered in Indianapolis, Indiana, is seeking candidates for a role within the Statistics, Data, and Analytics (SDnA) department. This position focuses on coordinating data submissions, ensuring data quality, and aligning with regulatory guidance across teams.

Ideal applicants have clinical data management experience, SAS/R skills, and knowledge of CDISC standards. Opportunities include partnering with global PK/PD, regulatory, and CROs to drive submission success.