BioSpace
Associate Director-Clinical Trials, Submission Data Delivery
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Associate Director-Clinical Trials, Submission Data Delivery Join to apply for the
Associate Director-Clinical Trials, Submission Data Delivery
role at
BioSpace . 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. We aim to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and support communities through philanthropy and volunteerism. We seek people who are determined to make life better for people around the world. Location note: This position requires living in the Indianapolis, IN area with a hybrid work arrangement (3 days onsite / 2 days remote). A relocation package may be included with offer.
Responsibilities
Lead all aspects of global consistency of medical data: structure, content and meaning, acquisition, storage, retrieval, interchange and representation.
Provide technical leadership and process ownership for Statistics, Data and Analytics.
Apply broad process/technology knowledge to ensure clinical trials are consistent and accurate.
Act as the main contact within Statistics, Data and Analytics for development and support of process and technology.
Communicate the global data strategy related to process and technology; influence to resolve regulatory and business issues.
Oversee submission data packages for SDTM, ADaM, PK/PD, and related data.
Liaise with product and study teams, submission teams, regulatory and vendors throughout submission preparation and post-submission data requests.
Develop and manage global process/technology strategy to facilitate reliable planning and execution of results.
Identify customer needs related to process/technology performance and improvements; optimize interfaces across Statistics, Data and Analytics.
Drive process improvement to reduce cycle time and enhance return on assets.
Basic Requirements
Bachelor’s degree in a scientific field.
Minimum 5 years of clinical trial data experience in drug development (e.g., clinical operations, statistics, IT, health outcomes, regulatory).
Legal authorization to work in the United States; no sponsorship anticipated for visa status.
Preferred Qualifications
In-depth experience with SDTM, ADaM, PK/PD and related data.
Proficiency with R, Python and SAS.
Strong understanding of the data submission process in clinical trials.
Project management and influencing submission teams; ability to report to stakeholders.
Knowledge of regulatory guidelines (FDA, PMDA, etc.) and experience with RIM.
Pinnacle 21 experience; define .xml, OSI, and other submission data deliverables.
Compensation and Benefits Actual compensation will depend on education, experience, skills, and location. Anticipated wage: $111,000 - $162,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program (401(k), pension, medical/dental/vision, life insurance, paid time off, and well-being benefits).
Lilly is an equal opportunity employer. We provide accommodations for applicants with disabilities as part of the application process. See our workplace accommodation resources for details.
Location and Company Info Company: Lilly (Indianapolis, IN). This posting reflects current job description for the Associate Director-Submission Data Delivery role with BioSpace as the posting platform.
WeAreLilly
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Associate Director-Clinical Trials, Submission Data Delivery Join to apply for the
Associate Director-Clinical Trials, Submission Data Delivery
role at
BioSpace . 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. We aim to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and support communities through philanthropy and volunteerism. We seek people who are determined to make life better for people around the world. Location note: This position requires living in the Indianapolis, IN area with a hybrid work arrangement (3 days onsite / 2 days remote). A relocation package may be included with offer.
Responsibilities
Lead all aspects of global consistency of medical data: structure, content and meaning, acquisition, storage, retrieval, interchange and representation.
Provide technical leadership and process ownership for Statistics, Data and Analytics.
Apply broad process/technology knowledge to ensure clinical trials are consistent and accurate.
Act as the main contact within Statistics, Data and Analytics for development and support of process and technology.
Communicate the global data strategy related to process and technology; influence to resolve regulatory and business issues.
Oversee submission data packages for SDTM, ADaM, PK/PD, and related data.
Liaise with product and study teams, submission teams, regulatory and vendors throughout submission preparation and post-submission data requests.
Develop and manage global process/technology strategy to facilitate reliable planning and execution of results.
Identify customer needs related to process/technology performance and improvements; optimize interfaces across Statistics, Data and Analytics.
Drive process improvement to reduce cycle time and enhance return on assets.
Basic Requirements
Bachelor’s degree in a scientific field.
Minimum 5 years of clinical trial data experience in drug development (e.g., clinical operations, statistics, IT, health outcomes, regulatory).
Legal authorization to work in the United States; no sponsorship anticipated for visa status.
Preferred Qualifications
In-depth experience with SDTM, ADaM, PK/PD and related data.
Proficiency with R, Python and SAS.
Strong understanding of the data submission process in clinical trials.
Project management and influencing submission teams; ability to report to stakeholders.
Knowledge of regulatory guidelines (FDA, PMDA, etc.) and experience with RIM.
Pinnacle 21 experience; define .xml, OSI, and other submission data deliverables.
Compensation and Benefits Actual compensation will depend on education, experience, skills, and location. Anticipated wage: $111,000 - $162,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program (401(k), pension, medical/dental/vision, life insurance, paid time off, and well-being benefits).
Lilly is an equal opportunity employer. We provide accommodations for applicants with disabilities as part of the application process. See our workplace accommodation resources for details.
Location and Company Info Company: Lilly (Indianapolis, IN). This posting reflects current job description for the Associate Director-Submission Data Delivery role with BioSpace as the posting platform.
WeAreLilly
#J-18808-Ljbffr