Pharmacometrician

职责描述：  Contribute to or conduct PK/PD data analysis and population modeling and simulation using industry standard software tools, including model building and refinement  Contribute to or conduct Model based Drug Development exercises for clients  Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize PK sampling and dosing strategies  Contribute to or conduct non-compartmental and compartmental pharmacokinetic analysis with rich sampling data as needed  Assist with providing strategic advice to clients and developing clinical pharmacology strategic plans and clinical protocol development  Work with other consultants to prepare and review pharmacometric reports and other clinical pharmacology documents.  Assist with development and validation of programming language in R for PK/PD data analyses  Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.  Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and support clinical studies and model development  Maintain current knowledge of advancements in modeling, simulation, PK, and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices to be able to contribute ideas to improve technologies and procedures for PK practices  Undertake diverse scaling approaches to design optimal dosing regimens for pediatric population.  Conduct biopharmaceutics data analyses (e.g. dissolution performance) with the objective to translate in vitro formulation performance to in vivo formulation performance in humans. 任职要求：  Degree in pharmaceutical science, physics, statistics, chemical engineering or related field. Experience in modeling/simulation strategies is highly desired.  Must have proven experience in quantitative pharmacology and strong hands-on modeling and simulation experience  Experience with population PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, GastroPlus, etc.)  Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.  Highly motivated individual with a strong intellectual and technical background in Pharmacometrics discipline  Excellent problem-solving, written and oral communication skills.

常经理 人事部 聊一聊

最近在线时间：2022-05-22 18:05

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地址：旧金山

联系我时就说是在 黑山 上看到的