Senior Associate - Clinical Pharmacology

Amgen SA; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen SA’s Clinical Pharmacology, Modeling and Simulation (CPMS) team seeks a Senior Associate to advance PK/PD analyses and reporting for clinical studies in Hyderabad. You will conduct formal data analyses, ensure quality control, and contribute to study reports while coordinating with data analysts and cross-functional partners.

Ideal candidates bring a PharmD/Bachelor's in Pharmacy and 5–9 years of total experience with 3 years in clinical pharmacology data analysis, including

Qualifications

• Bachelor’s degree with 5–9 years total experience and 3 years in clinical pharmacology data analysis.
• Experience with non-compartmental analysis and PK/PD datasets.
• Proficiency in Phoenix software and ADaM datasets.
• Strong written and verbal communication, and ability to work in cross-functional teams.

Responsibilities

• Execute formal PK/PD data analyses and summarize results for clinical study reports.
• Perform quality control of tables, figures, listings, and reports.
• Review and prepare standardized datasets to support analyses.
• Collaborate with CPMS data analysts and project teams to meet timelines.

Skills

Clinical pharmacology

Non-compartmental analysis

Data analysis

Teamwork

Communication skills

Education

Bachelor's degree in Pharmacy or related field

Master's degree beneficial

Tools

Phoenix

ADaM

Microsoft Office

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

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