Clinical Data Analyst Job in La Jolla 92121, California US
The successful candidate will have the ability to integrate pharmacokinetic (PK) data with information in the clinical database to ensure high quality clinical pharmacology data that enables appropriate analyses for successful regulatory submissions of oncology compounds.
-The candidate may conduct some preliminary programming work to generate PK datasets combined with clinical data, and some preliminary PK data analysis.
-The candidate may also review and modify submission-ready clinical pharmacology documents by demonstrating high attention to detail, in order to guarantee quality of the final document.
-The ability to work independently to think through results, resolve data discrepancies, analyze, interpret clinical data and focus on the key messages is essential.
-The candidate must be able to actively participate in cross-functional and clinical teams by explaining/promoting the clinical pharmacology strategy and data analyses and providing deliverables according to timelines.
Requirement
BS/MS degree with 3+ experiences in clinical trials.
-Must have a good understanding of principles of clinical pharmacology/pharmacokinetics as well as clinical trial operations.
-Experience with study and data management issues related to oncology studies is desired.
-An in-depth understanding in oncology statistics and hands-on experience with s-programming such as R/S-Plus, SAS, Winnonlin, OC-RDC would be a plus.
-Good oral and written communication skills and the ability to work effectively with people and teams is essential.
-The must haves are QC/QA skills, database skills and knowledge about pharmacokinetics.
-The nice to haves are programming skills, more advanced knowledge in pharmacokinetics and pharmacodynamics and knowledge of how to use R or Spotfire.