About the role
Job Responsibilities
- Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses.
- Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software
- Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results
- Participate in intra and/or extra company scientific consultancy
- Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies
- Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
- Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database.
- Write/review standard operating procedures related to his/her work
- Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
- Participate in the development of structured and standardized data modeling practices and related SOPs
- Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.)
- Perform comprehensive quality control/peer review procedures
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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