PKPD & PMx Data Scientist – PK Data Delivery

Lilly • Indianapolis, IN

5d • $90,000 - $195,800 • Onsite

About The Position

The PK Data Delivery (PKDD) team is embedded within Global PK/PD & Pharmacometrics and serves as a quantitative data partner across discovery and clinical development. The team delivers high-quality, analysis-ready and model-ready datasets and analytical outputs that support model-informed drug development decisions.

The Data Scientist will use programming and clinical data expertise to support PK data delivery, data quality, and process innovation. The role collaborates with cross-functional partners to ensure PK data are collected, transformed, validated, and delivered efficiently throughout drug development. Responsibilities include developing and independently validating PK analysis-ready datasets, PK-related SDTM domains, ADaM datasets, and TFLs in accordance with study specifications, CDISC standards, regulatory requirements, and company procedures. The position also partners with PMx and PK/PD clinical pharmacology leads from study design onward to anticipate analysis data needs, review data collection strategies and study materials, and resolve data-quality and readiness issues. The role develops R programming, automation, and AI-enabled solutions to improve the efficiency, quality, reproducibility, and scalability of PKPD data delivery.

Regular onsite presence is required at the assigned Lilly location in Indianapolis, Indiana (LCC). The position may be filled at different career levels, with placement determined by qualifications, experience, and demonstrated capabilities. Applicants must be authorized to work in the United States full time; Lilly will not sponsor work authorization or visas for this role.

Requirements

• Master's degree in Statistics, Biostatistics, Computer Science, Data Science, Mathematics, or a related quantitative field.
• Experience with R or SAS programming.
• Experience with clinical trial data structures, clinical data standards, and statistical analysis concepts.
• Must be authorized to work in the United States on a full-time basis; Lilly does not provide work authorization or visa sponsorship for this role.
• Regular onsite presence at the assigned Lilly location in Indianapolis, Indiana (LCC).
• Strong attention to detail, logical thinking, and problem-solving skills.
• Ability to manage competing priorities and tight deadlines, work independently with minimal supervision, adapt to evolving needs, and deliver quality results in a timely manner.
• Clear written and verbal communication and ability to build productive cross-functional partnerships.

Nice To Haves

• Experience developing SDTM datasets, ADaM datasets, and TFLs 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, such as Claude Code, in programming, data review, quality control, or workflow automation.
• Strong R proficiency, including package development, reproducible workflows, and version control with 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.

Responsibilities

• Collaborate with Data Management, Project Statisticians, Statistical Analysts, PK/PD project leaders, Pharmacometricians, and other partners to develop and independently validate PK analysis-ready datasets, PK-related SDTM domains, ADaM datasets, and TFLs.
• Ensure deliverables comply 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 data requirements for planned PK/PD and population analyses.
• Review data collection strategies, study documents, and clinical trial data throughout the study lifecycle.
• Identify, communicate, and resolve issues affecting PK data quality, traceability, analysis readiness, and downstream analyses.
• Develop and implement R programming, automation, and AI-enabled solutions to improve efficiency, quality, reproducibility, and scalability of PKPD data delivery processes.
• Communicate data issues and decisions in terms of their impact on analyses and programs, and engage stakeholders to advance project goals.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level