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‚Äôs degree and 3 years of relevant experience OR Bachelor‚Äôs 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 modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus); knowledge/experience in machine learning/AI tools; experience in PK/PD modeling and population-based analyses/simulations; excellent interpersonal, technical, and communication skills; previous record of scientific contributions through peer-reviewed articles and external presentations

Skills

• Data analytics and predictive analytics methodologies
• Pharmacometric and quantitative systems pharmacology modeling
• Modeling and simulation software (e.g., Python, Matlab, R, NONMEM, SAS)
• PK/PD modeling and population-based analyses
• Cross-functional collaboration and scientific communication

Education

• Doctorate (PhD, PharmD, or MD) or equivalent in a relevant field; or Master‚Äôs/Bachelor‚Äôs with sufficient experience as detailed above

Additional Requirements

• None essential beyond the above qualifications listed