Principal Scientist, Pharmacometrics Support

Role Overview

• Preparing R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK, PK/PD or Exposure Response analysis.
• Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
• QC NONMEM or ADNCA input dataset(s) generated by another PM support colleague.
• Generating e-submission package for NONMEM analysis, ensuring correct structure and format.
• Interacting with other departments and external vendors for data collection and training.
• Piloting generation of the first draft AI Authored data specification.
• Driving internal process improvements in dataset creation and QC procedures.

Requirements

• A minimum of a Bachelor’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or a related field with 8+ years of pharmaceutical development experience; or a Master's degree with 6+ years of pharmaceutical development experience; or a PhD with 4+ years of pharmaceutical development experience is required.
• Expertise with R programming language and R function creation is required.
• A fundamental understanding of clinical drug development and PK & PK/PD population PK modeling concepts is required.
• Good understanding of regulatory requirements and eCTD is required.
• Good understanding of AI driven approaches within data programming is required.
• Data-handling skills and solid understanding of clinical database structures such as SDTM and ADAM is required.
• Excellent written and oral communication skills with strong attention to detail are required.
• Ability to build and improve working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships) is required.
• Ability to collaborate in a diverse global environment is required.
• Self-motivation with the ability to work independently with minimal direction is required.
• Preferred: R Shiny programming experience is preferred.
• Prior knowledge with ADNCA and ADPPK dataset standards is preferred.
• Knowledge of principles of non-linear mixed effect modeling is preferred.
• Prior experience with pharmacometric analysis QC would be an asset.
• Experience within oncology and immunology is an asset.

Benefits

• medical, dental, vision, life insurance, short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours