Principal Statistician (Pharmacokinetics)
PSI CRO AGMunich, Bavaria, Germany
Posted September 9, 2025
Full Time
About the Company
We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.
Job Description
We are looking for 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, including the role of biostatistics project lead.
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