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.
Sr. Principle Clinical Data Strategist
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 3-5 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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