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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$96,000 - $162,800

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global 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.

The Clinical Study Build Programmer is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Portfolio Delivery:

Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components

Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives

Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)

Support submission, inspection and regulatory response activities

Lead cross Business Unit/Therapeutic Area projects or programs with high complexity

Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio

Project Management:

Increase speed, accuracy, and consistency in the development of systems solutions

Enable metrics reporting of study development timelines and pre and postproduction changes to database

Partner to deliver study database per business need and before first patient visit

Follow and influence data standard decisions and strategies for a study and/or program

Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data

Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables

Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making

Enterprise Leadership:

Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis

Represent Data and Analytics processes in multi-functional initiatives

Actively engage in shared learning across the organization

Work to Increase re-usability of forms and edits by improving the initial design

Work to reduce postproduction changes change control process

Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization

Interacts with regulators, business partners and outside stakeholders on business issues

Thinks with end to end in mind consistently managing risk to minimize impact on delivery

Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development

Focuses on defining database solutions and timelines in support of advancing the portfolio

Basic Qualifications:

Master’s degree with 5 years of experience in database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors(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

Additional Preferences:

Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.

Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.

Knowledge of CDISC and CDASH standards/standard terminology

Ability to work independently as well as in a team environment.

Minimum 4 years’ oncology experience preferred.

Project and Vendor management experience

Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.

Demonstrated ability to stay abreast of trends and new information in the profession.

Quick learner to new trends in technology

Excellent leadership, communication (written and oral) and interpersonal skills

Demonstrated teamwork and collaboration in a professional setting

Experience with the following:

Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions

Deciding the technology platform (system/database) for data acquisition and aggregation

Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)

Strong therapeutic/scientific knowledge in the field of research

Society of Clinical Data Management certification

Project management experience

Familiarity with clinical data tools and technologies

Understanding and experience in using data standards

Ability to balance multiple activities, prioritize and manage ambiguity

Demonstrated exemplary teamwork/interpersonal skills

Proven problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

Other Information:

Domestic and International travel may be required

Lilly currently anticipates that the base salary for this position could range from between $96,000 to $162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

 *To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

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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