Preparing R programming scripts to generate non-linear mixed effect modelling (NONMEM) analysis input dataset(s) for PK, PK/PD or Exposure Response analysis.
Modifying the variable definition file for dataset generation.
Generating Analysis Dataset Non-Compartmental Analysis (ADNCA) input datasets and associated Data Transfer Agreements and metadata.
Upon request, QC NONMEM or ADNCA input dataset(s) generated by another PM support colleague.
Generating e-submission package for NONMEM (or other modelling type) analysis.
Interacting with other departments (including but not limited to Data Management, Clinical & Statistical Programming, bio-analytical teams, Regulatory) and external Vendors.
Promoting better understanding across different departments.
Piloting the generation of the first draft AI Authored data specification.
Performing pharmacometric Analysis QC activities in support of the PM Leader.
Driving CPP internal process improvements in dataset creation, dataset QC, pharmacometric analysis QC procedures and e-submission package preparation.
Overseeing internal R package updates and maintenance.
Creating required training decks for internal use.
Actively participating in working groups related to AI assisted code generation.
Presenting (cross-departmental) process improvements within/outside the department.
Carrying out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.

Requirements

A minimum of a Master's degree in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or a related field 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.
Prior knowledge with ADNCA and ADPPK dataset standards is preferred.
R Shiny programming experience 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

R programmingR function creationnon-linear mixed effect modelingpharmacometric analysis QCADNCA dataset standardsAI driven approachesdata-handling skillsSDTMADAMeCTD

Soft Skills

written communicationoral communicationattention to detailrelationship buildingcross-functional teamworkcollaborationself-motivationindependence