The position supports the Pharmacometrics Leader in developing and executing Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation activities for products in any phase of development
Job Summary
The position supports the Pharmacometrics Leader in developing and executing Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation activities for products in any phase of development.
Responsibilities include preparing R programming scripts for NONMEM analysis, generating analysis datasets, performing QC, and creating e-submission packages.
The role involves interacting with various departments and external vendors to ensure data quality and promote understanding across teams, while also improving internal processes.
Matching Summary
The position supports the Pharmacometrics Leader in developing and executing Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling and Simulation activities for products in any phase of development.
Salary
Base: $109,000.00 - $174,800.00; Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, savings plan, paid time off
Skills & Requirements
Must-have
R programming language expertise
NONMEM analysis input dataset generation
e-submission package preparation
Clinical drug development understanding
PK/PK-PD modeling concepts
SDTM and ADAM data structures
Nice-to-have
R Shiny programming experience
AI prompting for R code
Oncology and immunology experience
Cross-departmental collaboration skills
Process improvement initiatives
Key Requirements
Master's degree with 5+ years experience OR PhD with 2+ years experience
Expertise with R programming language
Fundamental understanding of clinical drug development
Good understanding of regulatory requirements and eCTD
Data-handling skills and understanding of clinical database structures