Performs pharmacokinetic and pharmacodynamic data analyses, independently interprets PK and statistical results, conducts quality-control reviews, writes clinical reports, prepares regulatory submission files, maintains study documentation, and supports client interactions and internal presentations.
We are looking for a full-time Pharmacokinetic Scientist to join our Clinical Pharmacology team. This role may be based at either our Lincoln, NE, or Montreal, Canada facilities. Remote working relationships may be considered based upon experience. The Pharmacokinetic Scientist will assist with pharmacokinetic data analysis, scientific interpretation of study results, clinical report writing, and interactions with clients.
Essential Functions
- Data analysis and interpretation
- Perform PK analyses independently
- Assist with PD analyses
- Interpret PK and statistical results and findings independently
- Perform QC reviews as assigned
- Write and review reports as assigned
- Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies
- Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects
- Other responsibilities
- Interact with clients alongside or under direction of a senior scientist, as needed
- Prepare internal presentations
Requirements
- Master’s or PhD degree in a biology-focused sciences related field with 2+ years of related experience required
- Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin
- Familiarity with processes and applications related to non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling is an asset
- Excellent oral and written skills (English language) required
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Performs pharmacokinetic data analysis, PK and PD interpretation, quality control reviews, clinical report writing, regulatory filing preparation, and study documentation management. The scientist independently conducts PK analyses, supports client interactions, prepares internal presentations, and interprets statistical findings. The role requires collaboration with senior scientists and may involve nonlinear mixed-effects or physiologically based pharmacokinetic modeling.
Top Skills:
Noncompartmental Pharmacokinetic AnalysisNonlinear Mixed-Effects ModelingPhoenix WinnonlinPhysiologically Based Pharmacokinetic Modeling
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