Description
DESCRIPTIONThe Clinical Data Analyst will 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.
Responsibilities:
- Conduct some preliminary programming work to generate PK datasets combined with clinical data, and some preliminary PK data analysis.
- Review and modify submission-ready clinical pharmacology documents by demonstrating high attention to detail, in order to guarantee quality of the final document.
- Ability to work independently to think through results, resolve data discrepancies, analyze, interpret clinical data and focus on the key messages is essential.
- 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.
- BS/MS degree with at least three years of experiences in clinical trials.
- Knowledge of Clinical Documentation, Clinical Operations, Clinical Research, Data Validation and Database Management required.
- 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 programming such as R/S-Plus, SAS, S-Plus, Winnonlin, Oracle Clinical OC-RDC would be a plus.
- Regulatory experience as well as statistical analysis skills required.
- Good oral and written communication skills and the ability to work effectively with people and teams is essential.
- Must haves are QC/QA skills, database skills and knowledge about pharmacokinetics.
- Programming skills, more advanced knowledge in pharmacokinetics and pharmacodynamics and knowledge of how to use 'R' or 'Spotfire' desired.
SKILLS
MS Excel, Oracle Clinical, SS, S-Plus, WinNonLin, Clinical Documentation, Clinical Operations, Clinical Research, Data Validation, Database Management, Quality Assurance, Quality Control, Regulatory Experience, Statistical Analysis
Synectics is an Equal Opportunity Employer.