Senior Scientist: Data Analytics and Pharmacometric Modeling

Role Summary

Senior Scientist - Data Analytics and Pharmacometric Modeling

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

• Basic Qualifications: Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] Or Master’s degree and 3 years of relevant experience Or Bachelor’s degree and 5 years of relevant experience
• Preferred Qualifications: PhD in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD); 3+ years of experience in the life sciences, Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training; 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; Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is 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; Excellent interpersonal, technical, and communication skills to lead cross-functional teams; Previous record of scientific contributions through peer-reviewed articles and external presentations

Skills

• Modeling and simulation
• Pharmacokinetics/pharmacodynamics (PK/PD)
• Data analytics and predictive analytics
• Cross-functional leadership and collaboration
• Scientific communication and publication

Education

• PhD, PharmD, or MD (or equivalent post-doctoral training) preferred