Website Amgen ltd
Post Name: Senior Associate – Clinical Pharmacology
JOB ID: R-251028
LOCATION: India – Hyderabad
WORK LOCATION TYPE: On Site
CATEGORY: Clinical Development
he 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:
Bachelor’s degree with 5-9 Years of total experience and 3 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
