PKPD & PMx Data Scientist – PK Data Delivery

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. We are seeking a highly motivated individual with strong programming and clinical data expertise to support PK data delivery, data quality, and process innovation initiatives.

The successful candidate will collaborate with cross-functional teams to ensure PK data are collected, transformed, validated, and delivered efficiently to support decision-making throughout the drug development process.

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.

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.

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,…