Principal Scientist - Modeling & Simulation

Amgen; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental and Vision Insurance

Life and Disability Insurance

Flexible Spending Accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is seeking a Principal Scientist in Clinical Pharmacology, Modeling and Simulation to support PK/PD modeling across therapeutic areas. The role involves building pharmacostatistical models, applying Bayesian methods, and contributing to regulatory submissions.

You will work with cross-functional teams to inform dose selection, study design, and development strategy, with opportunities for professional growth and exposure to a broad pipeline.

Qualifications

• Doctorate degree PhD
• PharmD
• MD [and relevant post-doc where applicable] and 2 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
• 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

Responsibilities

• Building pharmacostatistical models to support Population PK/PD and exposure-response analyses.
• Conducting binary and categorical and time-to-event data analyses, Poisson models, MCMC and Bayesian methods.
• Performing meta-analysis using proprietary and/or literature data.
• Participating in cross-functional project teams and providing scientific input for dose selection and study designs.
• Contributing to clinical pharmacology strategy for the program and project plans.
• Generating modeling reports and contributing to regulatory submission documents.

Skills

Pharmacokinetics/PKPD modeling

Statistical modeling

Modeling software experience

Education

PhD

MD

PharmD

Master’s degree

Bachelor’s degree

Tools

NONMEM

SAS

R

STAN

MATLAB

Job description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Let’s do this. Let’s change the world. 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.

Key Responsibilities

• Building pharmacostatistical models to support Population Pharmacokinetics/Pharmacodynamic (PKPD) and exposure-response analyses using relevant state of the art modeling and simulation techniques.
• Conducting binary and categorical and binary 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.
• Performing meta-analysis using proprietary and/or literature data.
• Participating in cross-functional project teams and providing scientific input for dose selection, early and late study designs using modeling and simulation inputs.
• Contributing to clinical pharmacology strategy for the program(s) and implementing project plans.
• Generating modeling reports and contributing to the summary documents for regulatory submissions.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Principal Scientist we seek is a passionate professional with these qualifications.

Basic Qualifications

• Doctorate degree PhD
• PharmD
• MD [and relevant post-doc where applicable] and 2 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
• 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, bio-statistics, 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 bio-statistics of small molecules and/or biologics.
• Proficiency in modeling software (e. g. NONMEM, SAS, R/S-Plus, STAN, MATLAB)

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.