Manager-Submission Data Delivery

Eli Lilly and Company • Us, IN

3d • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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.

Requirements

• Bachelor’s degree
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

• 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.
• Experience with RIM, eCTD
• 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
• 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, Regulatory, TPO’s, other functional business partners and with external industry forums.
• Domestic and International travel may be required.

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 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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: Manager