Associate Director-Clinical Trials, Submission Data Delivery

Eli Lilly and Company•Us, IN

3d•Hybrid

About The Position

The Associate Director-Submission Data Delivery leads global consistency of medical data, including its structure, content and meaning, acquisition, storage, retrieval, interchange, and representation. The role requires an in-depth understanding of data collection, data flow management, data quality, data technology, data archiving, data standards, and the submission process. This position provides technical leadership and process ownership for Statistics, Data and Analytics. It is the organization’s main contact for process and technology development and support, and communicates the global data strategy across the organization. The role oversees submission data packages and works with product and study teams, submission teams, Statistics, Data and Analytics, regulatory groups, and vendors during submission preparation and in response to post-submission regulatory data requests. The position is based in the Indianapolis, Indiana area and operates in a hybrid capacity, with three days onsite and two days remote. A relocation package may be included with an offer.

Requirements

Bachelor’s degree, ideally in a scientific area.
At least 5 years of clinical trial data experience in drug development in intersecting areas such as clinical operations, statistics, information technology, health outcomes, or regulatory.
Must be legally authorized to work in the United States; employment visa sponsorship is not anticipated.

Nice To Haves

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, including influencing submission teams and reporting to stakeholders.
Understanding of regulatory guidelines and current expectations, including FDA and PMDA.
Experience with RIM Pinnacle 21, define.xml, OSI, and other submission data deliverables.

Responsibilities

Provide technical leadership and process ownership for Statistics, Data and Analytics.
Apply broad process and technology knowledge to ensure clinical trials are consistent and accurate.
Serve as the main contact within Statistics, Data and Analytics for process and technology development and support.
Communicate the global data strategy across the organization as it relates to process and technology.
Influence proactive resolution of complex regulatory and business issues related to process and technology.
Oversee submission data packages for SDTM, ADaM, PK/PD, and other data.
Liaise with product and study teams, submission teams, Statistics, Data and Analytics, regulatory groups, and vendors throughout submission preparation and post-submission regulatory data requests.
Define, deliver, and improve global processes and/or technology to facilitate reliable planning and execution of results.
Identify, monitor, and communicate global customer needs and requirements related to process and/or technology performance and improvements across therapeutic areas, regions, and functions.
Ensure process and/or technology interfaces are optimized across Statistics, Data and Analytics.
Continually seek and implement process improvements to reduce cycle time and work effort and improve return on investment of managed assets.

Benefits

Company bonus, depending in part on company and individual performance.
Eligibility to participate in a company-sponsored 401(k).
Pension.
Vacation benefits.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.
A relocation package may be included with an offer.