Senior Scientist: Data Analytics and Pharmacometric Modeling

Role Summary

Senior Scientist - Data Analytics and Pharmacometric Modeling. This role is part of the Clinical Pharmacology, Modeling and Simulation (CPMS) department, focusing on data science, predictive analytics methodologies and pharmacometric/quantitative systems pharmacology modeling to support drug development across therapeutic areas. You will design and execute an integrated predictive analytics strategy to complement pharmacometric modeling and help make robust inferences to support clinical development.

Responsibilities

• Designs modeling and simulation and analytics components of clinical drug development plans and provides expertise to project teams including plan, design, implementation and oversight of M&S plans for multiple programs in Amgen portfolio.
• Responsible for planning the analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Contributes to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels and to IND submissions and documentation of appropriate reports.
• Make recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and Development teams and in regulatory documentation.
• Influences external environment through methods such as publication and presentations.
• Responsible for communicating with partners (e.g. clinical pharmacologists, clinical assay group, statistics) to ensure appropriate support for programs and studies.
• Provide leadership, guidance and advice in own field, and develop innovative and creative output based on interpretation and analysis.

Qualifications

• Required: Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
• Required: Or Master’s degree and 3 years of relevant experience
• Required: Or Bachelor’s degree and 5 years of relevant experience
• Preferred: PhD in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD)
• Preferred: 3+ years of experience in the life sciences, Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
• Preferred: Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus, etc) is a plus
• Preferred: Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred
• Preferred: Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage
• Preferred: Excellent interpersonal, technical, and communication skills to lead cross-functional teams
• Preferred: Previous record of scientific contributions through peer-reviewed articles and external presentations