Associate Director-Clinical Trials, Submission Data 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

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This position requires living in the Indianapolis, IN area - working in a hybrid capacity which includes: 3 days onsite/2 days remote - a generous relocation package can be included with offer

The Associate Director- Submission Data Delivery role leads all aspects of global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in-depth understanding of data collection, data flow management, data quality, data technology, data archiving, data standards, and submission process.

Responsibilities:

The Associate Director-Submission Data Delivery provides technical leadership and process ownership for Statistics, Data and Analytics.

• Apply broad process/technology knowledge to ensure clinical trials are consistent and accurate
• Act as the main contact within the Statistics, Data and Analytics organization for development and support of process and technology
• Communicates the global data strategy across the organization as it relates to process and technology. Influence to proactively resolve complex regulatory and business issues related to process and technology
• Oversight of submission data packages for SDTM, ADaM, PK/PD, and other data.
• This role will liaise with product and study teams, submission teams, Statistics, Data and Analytics, regulatory and vendors throughout the submission preparation process and post submission regulatory requests for data.

Process/Technology Strategy Development and Management:

• Accountable for defining, delivering, and improving global processes and/or technology to facilitate the reliable planning and execution of results.
• Proactively identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and improvements as the need arises, across TA/Regions/Functions.
• Accountable for ensuring process and/or technology interfaces are optimized across Statistics, Data and Analytics.

Process Improvement:

• Continually seek and implement means of improving processes to reduce cycle time and decrease work effort to improve the return of the investment of the assets managed.

Basic Requirements:

• 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.)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Preferred Qualifications:

• In depth experience with SDTM, ADaM, PK/PD, and other data
• Experience with R, Python and SAS
• Strong technical experience and understanding of the data submission process in clinical data trials.
• Experience with project management and leading without authority, while influencing submission teams and reporting to stakeholders
• Understanding the regulatory guidelines and current expectations (FDA, PMDA, etc) along with experience with RIM
• Pinnacle 21 experience, define .xml, OSI, and other submission data deliverables

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$117,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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