PK/PD Submission Data Delivery Associate

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Job description

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: The Statistics, Data, and Analytics (SDnA) department is responsible for

• Portfolio - Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of PK/PD data sets, Integrated Data Bases and submission deliverables.

• People - Providing solution consultation to support Statistics, Data, and Analytics (SDnA) processes using process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents.

Primary 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.

• Submission Data Delivery (70%)

• This role will include overall project coordination of submissions and coordinate planning of submission data deliverables to ensure the development aligns with the compound's data strategy for the submission (i.e.(Data Definition Documents, XPTs).

• This role will leverage data expertise to ensure high-quality submission deliverables and stay updated on regulatory guidance in collaboration with other Lilly submission teams.

• Proactively identify, monitor and communicate customer needs/requirements related to process and/or technology performance and enhancements.

• Conduct monitoring and testing to ensure deliverable quality in the focus area.

• Adhere to best practices and global standardized business processes, as applicable to focus area.

• Process Management & Communication (15%)

• Build and maintain effective business partnerships with teams, functions, affiliates, and TPOs.

• Track & maintain process metrics.

• Provide root cause analysis as needed for process audits and assessments.

• Process Improvement (10%)

• Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.

• Represent SDnA and/or Global PK/PD processes in multi-functional initiatives.

• Actively engage in shared learning across Statistics, Data, and Analytics.

• Work with partners to increase vendor/partner efficiencies.

• Proactively identifies ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk.

• Asset Protection (5%)

• Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within Statistics, Data, and Analytics.

• Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties.

• Accept obligation to Lilly for compliance to the integrity of the company.

• Complete readings of any policy/procedure updates including global medical, SDnA, and local policies and procedures.

Basic Qualifications/Requirements

• Bachelor's degree

Other Information/Additional Preferences

• Experience in clinical data management and/or drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.) is highly preferred

• Demonstrated knowledge of clinical programming processes and technology.

• Demonstrated ability to understand and apply data flow, data quality, data interchange, data standards, and data representation principles.

• Solid understanding of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)

• SAS/R skills and other programming/statistical languages.

• Knowledge of CDISC format standards (SDTM, ADaM) and data standards

• Familiar with PK/PD NONMEM and NCA datasets

• Effective written and verbal communication skills in multi-cultural settings

• High learning agility, initiative, is flexible and has a positive demeanor

• Good interpersonal and leadership skills.

• Interpersonal/teamwork and communication skills for effective customer consultation.

• Strong business acumen.

• Demonstrated strength in logical thought, problem solving ability and critical thinking.

• Demonstrated ability to communicate and influence across SDnA, Global PK/PD, CDDA, TPO's, other functional business partners and with external industry forums.

• Domestic and International travel may be required.

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 ( ) 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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