Job Description

Career Category

Clinical

Job Description

The department of Clinical Pharmacology, Modeling and Simulation (CPMS) within Amgen is dedicated to the development of novel, effective, and safe medicines. We are seeking a highly experienced Senior Associate to join the CPMS group.

The successful candidate will contribute to Amgen’s multimodality development portfolio by conducting formal clinical pharmacology data analyses, summarizing pharmacokinetic/pharmacodynamic (PK/PD) data and results in clinical study report documents, performing quality control, reviewing PK/PD datasets, and adhering to applicable regulatory guidance (ie, good clinical practices [GCP]). In addition, the successful candidate will possess good written and oral communication skills, the ability to work well in teams, and will demonstrate technical aptitude and a strong work ethic. The individual will also be responsible for review and compliance with all applicable SOPs, business practices and company policies.

The primary core responsibilities of the Senior Associate will include:

• Execution of formal PK/PD data analysis and report writing for clinical studies with a strong emphasis on quality and meeting timelines
• Perform quality control of analyses and outputs (ie, tables, figures, listings, and reports) to ensure accuracy and consistency in accordance with standard processes
• Review and create standardized datasets supporting clinical pharmacology analyses
• Work closely with CPMS data analysts and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally

Basic Qualifications

Master’s degree and 5 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis

OR

Bachelor’s degree and 7 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis

Preferred Qualifications

• Bachelor’s or Master’s degree in Pharmacy preferred, but can also be in related fields such as biology, chemistry, or biochemistry.
• Following skills are required:
• good understanding of clinical pharmacology and pharmacokinetic/pharmacodynamic concepts
• experience in conducting non-compartmental analysis
• experience working with clinical pharmacology datasets and report writing
• experience in working with Phoenix analysis software and with standardized analysis datasets (ADaM)
• Familiar with the drug development process, regulatory guidelines (including Good Clinical Practices), analysis methodology, and clinical pharmacology studies
• Skilled in using Microsoft Office software (ie, Word, Excel, PowerPoint)
• Able to work under tight deadlines
• Strong analytical, writing, communication, organization, and teamwork skills