PKPD & PMx Data Scientist – PK Data Delivery

BioSpace; Indianapolis (IN); On-site; USD 90,000 - 196,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits

401(k) plan and retirement benefits

Job summary

Lilly's PK Data Delivery (PKDD) team seeks a quantitative data partner to create analysis-ready datasets and TFLs, aligned with CDISC standards and regulatory requirements. You will collaborate with statisticians and PK/PD leads to anticipate data needs and ensure data readiness throughout studies.

The role emphasizes R programming, automation, and AI-enabled tooling to enhance efficiency and reproducibility, with onsite work at Indianapolis, IN.

Qualifications

• Master's degree in Statistics, Biostatistics, Computer Science, Data Science, Mathematics, or a related quantitative field.
• Experience in R or SAS programming.
• Experience with clinical trial data structures, clinical data standards, and statistical analysis concepts.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Develop and independently validate PK analysis-ready datasets, PK-related SDTM domains, ADaM datasets, and TFLs.
• Collaborate with Data Management, Project Statisticians, and PK/PD Leads across study lifecycles.
• Develop and implement R programming, automation, and AI-enabled solutions to improve efficiency and reproducibility.

Skills

R programming experience

SAS programming experience

Statistical analysis concepts

Clinical trial data structures

Data quality and traceability

Education

Master's degree in Statistics or related quantitative field

Tools

R

SAS

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.

Overview

The PK Data Delivery (PKDD) team is embedded within Global PK/PD & Pharmacometrics and is the quantitative data partner across discovery and clinical development. We deliver high-quality, analysis-ready and model-ready datasets and analytical outputs that enable model-informed drug development (MIDD) decisions.

You Will Have The Opportunity To

Collaborate with Data Management, Project Statisticians, Statistical Analysts, PK/PD project leaders, Pharmacometricians, and other cross-functional partners to develop and independently validate PK analysis-ready datasets, PK-related SDTM domains, ADaM datasets, and Tables, Listings, and Figures (TFLs) in compliance with study specifications, CDISC standards, regulatory requirements, and company procedures.

Partner with PMx Leads and PK/PD (clinical pharmacology) Leads from study design onward to anticipate the data requirements of planned PK/PD and population analyses, review data collection strategies, study documents, and clinical trial data throughout the study lifecycle, and identify, communicate, and resolve issues impacting PK data quality, traceability, analysis readiness, and downstream analyses.

Develop and implement innovative R programming, automation, and AI-enabled solutions to improve efficiency, quality, reproducibility, and scalability of PKPD data delivery processes.

Basic Qualifications

This position may be filled at different career levels. Placement will be determined based on the candidate’s qualifications, relevant experience, and capabilities demonstrated.

• Master's degree in Statistics, Biostatistics, Computer Science, Data Science, Mathematics, or a related quantitative field.
• Experience in R or SAS programming.
• Experience with clinical trial data structures, clinical data standards, and statistical analysis concepts.
• 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.

Additional Requirements

This position requires regular onsite presence at the assigned Lilly location (Indianapolis, IN, LCC).

Additional Skills / Preferences

• Experience developing SDTM datasets, ADaM datasets, and TFL in a regulated clinical development environment.
• Experience supporting PK data readiness activities and developing PK analysis-ready datasets for PK/PD and PMx analyses.
• Experience with FDA, EMA, ICH, and CDISC standards and guidelines.
• Knowledge of clinical trial processes and drug development.
• Experience reviewing study design, data collection strategies, and study documentation to support PK or PK/PD analyses.
• Experience using AI coding assistants and agentic workflows (e.g., Claude Code) in programming, data review, quality control, or workflow automation.
• Strong R proficiency, including package development, reproducible workflows, and version control (Git).
• Experience or training in pharmaceutical, biotechnology, CRO, or clinical research environments.
• Exposure to population PK/PD or pharmacometric modeling, including dataset conventions for NONMEM, Monolix, or similar tools.
• Strong attention to detail and clear written and verbal communication with scientific and clinical partners.

Success Factors

Ownership & Execution

Demonstrates strong attention to detail and commitment to data integrity.

Applies strong logical thinking and problem-solving skills to programming and data-related challenges.

Is self-motivated, accountable, and committed to delivering high-quality results in a timely manner.

Adaptability & Learning

Thrives in a fast-paced, high-demand environment and effectively manages competing priorities, evolving project needs, and tight deadlines.

Actively learns new methods and tools, including AI-assisted ways of working, and applies them to real deliverables rather than waiting for dedicated training time.

Demonstrates flexibility, works independently with minimal supervision, and willingly steps up to support team priorities when needed.

Collaboration & Impact

Communicates data issues and decisions in terms of their impact on the analysis and the program, so partners can act on them.

Builds productive partnerships across functions and proactively engages stakeholders to advance project goals and business outcomes.

Demonstrates ownership by proactively addressing issues, challenging organizational silos, driving cross-functional alignment, and overcoming obstacles that impact quality, efficiency, or project success.

Shows persistence, courage, resilience, and a results-oriented mindset in addressing difficult or longstanding challenges, making tangible progress, driving complex initiatives to successful outcomes, and continuously seeking opportunities for improvement.

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 $90,000 - $195,800.

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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