Are you an early career PK Data analyst looking for a good place in the DC/MD/VA area to grow in your career? If you have successfully been using WinNonlin software with bioanalytical data and enjoy interacting with data managers and statisticians to advance new, potential life-saving therapeutics, this opportunity could be for you. This position will have influence, key impact, and strong career growth. You should have a BS with 6+ years experience, an MS with 3+ years, or a PhD with 0-2 years, preferably in a pharma, biotech, or CRO company. Excellent opportunity for long term development.
- The PK Data Analyst will perform WinNonlin parameter calculations and provide support to biostatistics and data management for Phase1/2 trials. This includes reconciling all the PK samples obtained from the clinical lab, running bioanalysis, calculating parameters per protocol, reviewing statistical analysis plans and shells to make sure it aligns with study requirements, communicating with Data management and statistics team on an ongoing basis to support file transfers.
- This position requires knowledge of PK data as well as basic SAS programming to perform reconciliations.
- Experience of 3-4 yrs working with PK data in Phase 1 setting is desired.
- Review Statistical Analysis Plans for PK portion of the protocol
- Create PK concentration and PK parameter files under guidance of PK scientist
- Able to reconcile PK samples obtained from clinics against protocol requirements
- Develop QC plan to ensure sample tracking
- Able to understand and resolve queries from data management and statistics department regarding SAP/shells
- Able to resolve any data issues and queries from data management and statistics dept
- Responsible for the QC of data received from external vendors in addition to the QC of deliverables before delivering to the DM/Stats dept
- Responsible for organization of study PK related documents, ensuring data and test transfer files are QC/QA ready
- Keeps management abreast of issues and progress on all assigned projects
- May provide general guidance to laboratory coworkers.
- * May train lower level support staff within assigned department.
Required Education and Experience
- PhD or Master of Science in relevant field, OR Bachelor of Science in relevant field and at least 3-4 years relevant experience.
- Track record of knowledge and in depth use of WINNONLIN software
Preferred Education and Experience
- SAS programming
- Mathematics /Statistics focus
- Experience in early clinical studies is a plus
To apply for this position, confidentially email us here.