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Clinical Pharmacology Analyst

American Regent, Inc. • Remote, PA
2 days ago

Support the clinical development process by:


Providing in depth expertise in the analysis and reporting of clinical pharmacokinetic (PK) and pharmacodynamic (PD) trials with focus on noncompartmental analyses (NCA); modelling and simulation; and generating tables and graphs.

Contributing to understanding the dose-exposure-biomarker-response/clinical end-point relationships and to maximizing translational knowledge generation.

Championing the use of quantitative methods for optimizing drug development.

  • Develop and execute pharmacokinetics and pharmacodynamics analytical approaches, population pharmacokinetic models, exposure-response models, quantitative system pharmacology, and other model-based analyses.
  • Support the review of clinical study protocols, dataset specifications and analysis plans, and clinical study reports for assigned projects.
  • Develop and maintain new template codes, macros or processes for the analysis of PK and PK/PD data with SAS or WinNonlin
  • Develop and maintain template code and macros for the generation of PK and PK/PD tables and graphs
  • Participate in relevant meetings (e.g. project team, study team, data review) to allow effective preparation and execution of analyses and reporting.

Basic Qualifications

  • Masters or equivalent degree in pharmacometrics, mathematics, statistics/ biostatistics, or computational biology/chemistry with 5 years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia OR
  • Bachelor’s degree in pharmacometrics, mathematics, statistics/ biostatistics, or computational biology/chemistry with 7 years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.

Preferred Qualifications

  • In depth experience and proficient in the use of pharmacokinetic/pharmacodynamic concepts and the PK/PD noncompartmental analyses, data handling and evaluation according to GCP, and reporting of clinical trials.
  • Experience with standard pharmacometric software (e.g., NONMEM, Phoenix, etc.).
  • Good working knowledge of SAS programming language.
  • Comprehensive understanding of regulatory requirements for Bioequivalence
  • Experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
  • Knowledge in database structures and set-up.
  • Knowledge of basic medical terminology.
  • Good organizational skills, problem-solving abilities, time management skills and initiative.
  • Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
  • Good written and oral communications skills in the English language.
  • Must be precise, detail oriented, and able to understand data displays and their relation to each other.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at 631-690-7201 or email at HRTalentAcquisition@americanregent.com