Sr. Principal - Clinical Data Strategist

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Purpose:

The Clinical Data Strategist is a cross functional Data and Analytics scientific leader and key partner with other Data and Analytics Leaders and cross functional staff. Clinical Data Strategist is accountable for setting end to end clinical data strategy, driving cross functional alignment, and realizing improvements in drug development data solutions, technologies, data processes, data products and/or services for a Business Unit and Therapeutic Area. The scope of the Clinical Data Strategist role includes elements of clinical research from early clinical development to post launch clinical research activities.

Primary Responsibilities:

Portfolio Delivery

• Partner with internal and external teams to provide proactive strategic, scientific and technical input for clinical data planning and execution that enable efficient delivery of data

• Accountable for driving project decisions related to clinical data execution options, including integrated functional sourcing, technology, automation, analytics and data collection modality

• Ensure strong linkages exist between clinical design, execution, analytics, delivery and submission

• Ensure data from different sources are consistent and easily consumable

• Map collected data into predictable source/raw data

• Collaborate with Clinical Data Associate and other Data and Analytics staff on data collection design

• Understand inconsistencies in data and provide feedback to standards team

• Support submission, inspection and regulatory response activities

People Management and Development

• Contribute to an agile organization that continuously meets the needs of a changing portfolio

• Coach up staff who demonstrate expertise in drug development, therapeutic area science, project management and all aspects of clinical data sciences and solutions

• Demonstrate and encourage judgment-based scientific decision making, and provide leadership in clinical data strategy, standardization, integration, analytics, automation and data submission

• Provide scientific and technical leadership, coaching, and example to the community of Data & Analytics professionals

• Foster inclusion, innovation and promote diversity

Basic Qualification:

• Master’s degree with minimum 3 years of experience in data management (or Bachelor’s degree with 7 or more years of experience)

• 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:

• Advanced degree (e.g. MSc, PhD) in a scientific or health care field

• Experience in clinical drug development with expertise in clinical data management, leading asset level clinical data strategies, defining clinical data flows, determining data modalities and/or defining requirements for data integration, mapping and normalization.

• Demonstrated ability to effectively partner/influence to deliver results

• Demonstrated ability to understand and apply clinical data management skills, including data flow, data structures, data quality & integrity, data interchange, data mining, and data representation principle

• Demonstrated knowledge of clinical concepts and expertise at the indication and compound level

• Ability to translate protocol language into data needs

• Solid understanding of CDISC and evolving industry practices

• Proven ability to lead development of creative data solutions to address clinical development challenges

• Proven ability to develop diverse organizational talent with next level potential

• Passionate about improving technological solutions using new technologies

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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