Pharmacometrician
1 month ago
This position requires collaboration with cross-functional teams to develop model-informed drug development (MIDD) plans for assigned projects, optimizing prospective studies and informing drug development strategy.
Key Responsibilities- Conduct and report quantitative analyses integrating pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens, and study designs.
- Identify opportunities to advance understanding of pharmacological activity, efficacy, and safety through MIDD approaches.
- Provide support in developing and applying state-of-the-art quantitative methodologies, pharmacometrics tools, software, hardware, and business processes.
- Provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians to create MIDD plans.
- Execute relevant quantitative analyses, including population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis, quantitative knowledge management, and decision analysis.
- Prepare formal presentations and written reports to Pfizer standards.
- Contribute to regulatory documents, including summary documents, briefing books, and regulatory responses.
- Stay abreast of literature, government guidelines, and internal guidance on pharmacometrics and MIDD.
- PhD in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Engineering, Pharmaceutical Sciences, or PharmD.
- Strong quantitative modeling skills, including pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, and statistics.
- Experience with R software.
- Strong communication skills, including written, oral, and presentation.
- Industry experience in Pharmacometrics, Clinical PK/PD, and/or Clinical Pharmacology.
- Experience with Nonmem, PsN, MATLAB, or other pharmaceutical software.
- Experience with other statistical software, such as Stan.
- Programming experience, including Python and C++.
- Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology.
- Matrixed relationships with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required.
- Sitting, ability to perform complex data analyses.
Work Location Assignment: On Premise
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