Associate Director – Data Standards

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

The purpose of the Associate Director – Data Standards role is to be responsible for providing technical leadership and 
ownership for data standards across the clinical trial dataflow.

The main responsibilities of this role are: 

• Developing standards to be used and followed at each stage of the clinical trial dataflow. 
• Maintaining libraries of clinical trial data standards accessible to relevant Lilly personnel. 
• Ensuring facility of data transfer between Lilly and external partners by defining relationships between internal and external standards. 
• Developing metadata used to control and automate the clinical trial dataflow process.

Primary Responsibilities:

The job tasks listed below outline the scope of the position. The application of these tasks may vary based on current business needs. 

Data Standards Development and Maintenance (60%): 

• Collaborate on standards for collected data elements (e.g., terminology) 
• Develop standards for transformations of source data into observed and analysis datasets, including derived variable standards. 
• Develop metadata used to automate and control the clinical trial dataflow process. 
• Maintain standards-compliant library components (i.e., forms, panels, rules, derivations). 
• Influence the organization to adopt standards and ensure that standards are created in a timely way when not available. 
• Ensure replication of tools and systems, where applicable, and stay informed of technology advances. 

Deliverable Ownership (15%): 

• Collaborate with Statistics colleagues and study personnel to ensure compliance to industry data standards.

External Influence (10%): 

• Engagement with external data standards organizations (i.e., CDISC). 
• Participation on external committees to develop and influence industry standards. 
• Understand data standards external to Lilly (e.g., CDISC) and facilitate mapping between internal and external data standards for regulatory submissions and when dealing with vendors and other third parties.

Process Improvement (10%): 

• Continually seek and implement means of improving processes to automate, reduce cycle time and decrease work effort. 
• Represent Standards organization’s processes in cross-functional initiatives. 
• Actively participate in shared learning. 
• Work with partners to increase vendor/partner efficiencies.

Asset Protection (5%): 

• Understand the confidential nature of company information and take necessary steps to ensure its protection. This includes understanding various aspects of privacy as it relates to the clinical trial data. 
• Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties. 
• Complete readings of any policy/procedure updates, including global medical, departmental, and local policies and procedures.

Minimum Qualification Requirements:

• Master’s degree in Medical Informatics, Information Technology or Statistics- or bachelor’s degree and 5 years’ experience in clinical data management, data standards, IT or statistics. 
• 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.

Other Information/Additional Preferences:

• Strong interpersonal and leadership skills. 
• Excellent oral and written communication skills. 
• Project management skills. 
• Familiarity with SQL, ORACLE, XML. 
• Knowledge of medical terminology. 
• Vendor management/oversight skills. 
• Domestic and International travel may be required.

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 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

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; and 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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