- Conducts clinical pharmacokinetic (PK) and pharmacodynamic (PD) data analysis according to GCP and appropriate protocol, PKAP, SOPs, as responsible pharmacokineticist.
- Conducts non-clinical pharmacokinetic (PK) and toxicokinetic (TK) data analysis according to GLP and appropriate protocol, SOPs, as contributing scientist or principal investigator.
- Ensures mechanisms are in place to maintain flow of appropriate information between disciplines on project teams.
- Responsible to draft protocols, pk analysis plan (PKAP) and amendments, using proposal outline or client-supplied information, to include methodology, definition of derived variables and data-handling rules.
- Communicates and interacts with study team, other departments and clients as applicable.
- Assists in the development and maintenance of standard report/table formats as needed.
- Plans, prioritizes and manages own workload and multiple responsibilities.
- Independently use project tracking systems as appropriate.
- Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
- Responsible for report preparation, including table and figure preparation.
- Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
- Minimum Bachelor of Science/Arts (BS/BA) degree with 2-3 years working experience
- Experience may be substituted for education.
- Efficient use of word processing software, database, spreadsheet and specialized software
- Proficient in concise writing. Writing should require little or no external review or edit.
- Adherence to grammar, punctuation, composition and spelling accordingly to company standard conventions.
- Experience on a variety of studies performed in the department and exposure to a diverse client base.
- Knowledge of regulatory agency guidance.
- At least two years related or relevant experience.
- Be familar with Phenonix Winnonlin
- The experience of NONMEM, R or SAS is a plus
- Excellent communication, presentation and interpersonal skill.
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