Principal Scientist - Modeling & Simulation

About the role

In this vital role you will support Amgen clinical development and translational sciences programs across multiple therapeutic areas as part of the Clinical Pharmacology, Modeling and Simulation department.

Responsibilities

• Build pharmacostatistical models to support Population Pharmacokinetics/Pharmacodynamic (PKPD) and exposure-response analyses using relevant state-of-the-art modeling and simulation techniques.
• Conduct binary and categorical data analyses, time-to-event (hazard) models, Poisson models, MCMC and Bayesian methods as applied to exposure-response analyses and Population PK and PKPD analysis.
• Perform meta-analysis using proprietary and/or literature data.
• Participate in cross-functional project teams and provide scientific input for dose selection, early and late study designs using modeling and simulation inputs.
• Contribute to clinical pharmacology strategy for the program(s) and implement project plans.
• Generate modeling reports and contribute to the summary documents for regulatory submissions.

Qualifications

Basic Qualifications

• Doctorate degree (PhD, PharmD, or MD) and 2 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience, or relevant post-doc where applicable.
• Master’s degree and 5 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience.
• Bachelor’s degree and 7 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience.

Preferred Qualifications

• PhD in pharmaceutical sciences, applied statistics/mathematics, biostatistics, and/or engineering or related fields with equivalent professional degrees (e.g., MD, PharmD) with 3 years of PK/PD or statistical modeling experience.
• 5+ years industry or relevant academic experience in pharmacometric analyses and/or applied biostatistics of small molecules and/or biologics.
• Proficiency in modeling software (e.g., NONMEM, SAS, R/S-Plus, STAN, MATLAB).

Benefits

• Comprehensive employee benefits package, including:
  • Retirement and Savings Plan with generous company contributions.
  • Group medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.