Principal - Clinical Study Build Programmer

2 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

Responsibilities:

Advisor- 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.

The Clinical Data Strategist is responsible for consulting with and/or developing staff to enhance scientific, technical, and operational depth. This role requires an in depth understanding of end to end global clinical data sciences and clinical data management, including data base structures, data collection methods, data flow management, data analytics and automations, data quality & integrity, data technology, data archiving, data standards, data integration, data mapping/normalization and data submission.

1. Portfolio Delivery

Partner with Data and Analytics staff and key Business Unit/Therapeutic Area leaders to provide proactive strategic, scientific and technical input for clinical data planning and execution that enable efficient delivery of dataPartner with the Design Hub and asset teams to ensure clinical data strategies and plans are understood and effectively incorporated into clinical plans, protocols, data strategies, data standards and plan documentsAccountable for driving project decisions related to clinical data execution options, including integrated functional sourcing, technology, automation, analytics and data collection modalityEnsure strong linkages exist between clinical design, execution, analytics, delivery and submissionDrive efficiency and continuous improvement in the Data and Analytics organization and, as appropriate, cross-functionally to support Therapeutic Area and Business Unit aligned deliverablesIdentify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delaysEnsure data from different sources are consistent and easily consumable
• Map collected data into predictable source/raw dataAccountable for specifications for raw data at study level ensuring consistent, standardized and easily consumable dataCollaborate with Clinical Data Associate and other Data and Analytics staff on data collection designPartner effectively with stat analysts and statisticians, translating programming and analysis needs into source data elements and formatsArticulate programming needs to complete normalization of data from various sources into clinical data warehouseUnderstand inconsistencies in data and provide feedback to standards teamSupport submission, inspection and regulatory response activitiesLead large-scale cross Business Unit/Theraputic Area projects or programs with high complexityDevelops and tests new ideas and/or applies innovative solutions that create value to the portfolioIndependently identifies key scientific questions/issues and develops solutions to advance the portfolio2. Enterprise Leadership Exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs Represent the Data and Analytics organization at appropriate internal and external venuesAccountable for fiscal responsibility of execution of clinical data plansEnsure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulationsDrive shared learning and end to end process expertise, demonstrating continuous improvement on key metricsProactively define and drive data strategies to accelerate data execution, delivery, integration and submissionBring greater value to the portfolio by anticipating issues and identifying opportunities for which data solutions can be applied regardless of sourceArticulate the value of data solutions in terms of reliability, time, cost, quality and scalabilityIntegrates cross-functional and/or external information and applies technical knowledge to data-driven decision makingAnticipate and resolve key technical, operational or business problems that impact the Data and Analytics organizationInteracts with regulators, business partners and outside stakeholders on business issuesThinks with end to end in mind consistently managing risk to minimize impact on delivery3. People Management and Development Support efforts to recruit, develop, and retain a scientific, technical and operationally capable workforce skilled and knowledgeable in end to end global clinical data strategies, data base structures, data normalization, automation, analytics and data integration .Effectively create and support an agile organization that continuously meets the needs of a changing portfolioDevelop staff who demonstrate expertise in drug development, therapeutic area science, project management and all aspects of clinical data sciences and solutionsDevelop an organizational talent base that demonstrates judgment-based scientific decision making, and provides leadership in clinical data strategy, standardization, integration, analytics, automation and data submissionProvide scientific and technical leadership, mentoring, coaching, and example to the community of Data & Analytics professionalsFoster inclusion, innovation and promote diversityBasic Qualifications:Master's degree with more than 5 years of experience (or Bachelor's degree with 7 or more years of 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.​Additional Skills/Preferences:Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities.Demonstrated ability to effectively partner/influence to deliver resultsDemonstrated ability to understand and apply clinical data management skills, including data flow, data structures, data quality & integrity, data interchange, data mining, and data representation principleDemonstrated knowledge of clinical concepts and expertise at the indication and compound levelAbility to translate protocol language into data needsWorking knowledge of CDISC and evolving industry practicesAdvanced degree (e.g. MSc, PhD) in a scientific or health care fieldPrevious supervisory experienceProven ability to lead development of creative data solutions to address clinical development challengesProven ability to develop diverse organizational talent with next level potentialPassionate about improving technological solutions using new technologiesSociety of Clinical Data Management certificationAdditional Information:Domestic and International travel may be require Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. #WeAreLilly

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