Job Summary: Perform data analyses, study design, and review of clinical trial reports.
Key Responsibilities:
- Perform pharmacokinetic analysis for Phase I-IV clinical trials
- Perform pharmacokinetic and statistical analysis for comparative bioavailability trials
- Execute pharmacokinetic and/or pharmacodynamic modeling as required
- Prepare well researched study designs
- Review protocol and study reports for scientific content, data accuracy and compliance with current regulatory guidelines
- Responsible for acquiring and maintaining knowledge of national and international guidelines
- Develop, write, implement and maintain standard operating procedures related to the Scientific Affairs department
- M.Sc. or higher in a relevant scientific discipline
- Experience in design and conduct of bioavailability and bioequivalence studies
- User-level knowledge of pharmacokinetic and statistical software
- Excellent English communication skills
- Ability to work effectively in a team environment