Senior Associate - Clinical Pharmacology

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

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