Manager-Submission Data Delivery

BioSpace; Indianapolis (IN); On-site; USD 65,000 - 149,000; Full time

Benefits offered by this job

401(k) plan

Comprehensive benefits

Paid time off

Job summary

Lilly is seeking a data/SDnA professional to support submission data delivery and regulatory data standards. You will coordinate submissions, ensure data quality, and collaborate with global teams to advance drug development programs.

Strong knowledge of SDTM/ADaM, SAS, and regulatory guidelines is essential. Responsibilities include process improvement, data governance, and confidentiality compliance in a fast-paced environment with international travel.

Qualifications

• Bachelor’s degree required in a related field.
• Experience with clinical data management and drug development preferred.
• Knowledge of data flow, data quality, and regulatory data standards.

Responsibilities

• Coordinate submissions and plan submission data deliverables.
• Ensure high-quality submission deliverables with regulatory guidance.
• Provide root cause analysis during audits and assessments.
• Improve processes to reduce cycle time and increase efficiency.
• Protect confidential information and ensure privacy compliance.

Skills

SAS

R

CDISC SDTM/ADaM

GCP knowledge

Statistical analysis

Education

Bachelor's degree

Tools

RIM

eCTD

Job description

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.

Responsibilities

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.

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

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

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.

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.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$65,250 - $148,500

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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