Associate Director-Clinical Trials, Submission Data Delivery

Associate Director- Submission Data Delivery

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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 for further assistance.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $111,000 - $162,800. 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.