Sr. Principal - Clinical Data Strategist

Eli Lilly • Indianapolis, IN

114d • $121,500 - $198,000

About The Position

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. 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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree