Associate Director-Clinical Trials, Submission Data Delivery

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.

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* Preferred Qualifications:

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* + In depth experience with SDTM, ADaM, PK/PD, and other data

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Experience with R, Python and SAS

+ Strong technical experience and understanding of the data submission process in clinical data trials.

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Experience with project management and leading without authority, while influencing submission teams and reporting to stakeholders

+ Understanding the regulatory guidelines and current…