Principal Statistician (Pharmacokinetics)
PSI CRO AGDurham, North Carolina, United States
Posted September 9, 2025
Full Time
About the Company
A dynamic, global company founded in 1995, with over 2,700 employees working on the frontline of medical science.
Job Description
We are seeking a Principal Statistician (Pharmacokinetics) to contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers.
Requirements
- MSc in Statistics or equivalent
- Full working proficiency in English
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- Expert knowledge and understanding of the SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Expert knowledge and understanding of pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis
- Expert knowledge and understanding of Phoenix WinNonlin and NLME
- Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
- Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
- Strong presentation and communication skills