David Tran

San Francisco, CA

415-***-**** acti1a@r.postjobfree.com

EXPERIENCE

**/** – 06/15 Statistical (SAS) Programmer Parexel Decentralized, USA

•Create DDS for SDTM/ADaM datasets and create respective datasets (using Protocol, IG, Data Specs)

•Annotate CRFs to SDTM standard

•Program supplemental & custom domains according to CRF mapping

•Develop the required expertise in all SAS PROCs that are needed to generate the analyses.

•Generate Integrated Summaries of Safety (ISS)

•Create outputs using ODS option into formats (RTF, PDF, Excel)

06/14 – 12/14 Statistical (SAS) Programmer Amgen Decentralized, CA

•Mapped raw data variables and defined specifications for derived datasets

•Programmed & validated analysis datasets, TLFs, ad hoc reports, and Mock Shells as per SAP

•Developed Macros for repetitive processing of parameters to improve efficiency

•Good working knowledge of CDISC SDTM Implementation Guidelines and ADaM

•Collaborated with Biostatisticians & Data Management on current studies

07/13– 06/14 Data Support Associate II Gilead Sciences Foster City, CA

•Generated, tracked and controlled laboratory records, analysis reports and data files

•Conducted data querying and reporting across multiple database (e.g. LIMS, IQS, Trackwise)

•Developed & supported data management tools (e.g. electronic indexing, websites & spreadsheets)

•Supported exception investigations (e.g. deviations, laboratory investigations, CAPAs)

•Created and reported metrics for various workflows (sample pulls, test starts)

•Provided training in support of good documentation practices SOP, and CAPA efforts

06/12– 05/13 Research Associate Novartis San Carlos, CA

•Ran phase III clinical testing trials for nebulizer medical devices (drug used for testing: Amikacin Sulfate). To determine flow rate, volume mean diameter (VMD) and particle size, correlating to efficiency and effectiveness

•Types of test methods performed on nebulizers: Use-Life, Functional, and Patient-Use Scenario (PUS)

•Computer software and equipment used: Pulmonary drug delivery system (PDDS) Release, Malvern Spraytec

03/11 – 06/12 QC SAP/LIMS Data Implementer Bayer Pharmaceuticals Berkeley, CA

•Reviewed and transcribed data from Sapphire LIMS & SAP and resolved incomplete datasets

•Verified & Final released test results in SAP from the QC department to initiate production for the manufacturing department

•Transcribed data from Sapphire LIMS & old SAP system to the new SAP system

•Reviewed Sapphire LIMS sample data for deficiencies and resolving incomplete datasets

•Verified test results from sampling handling office onto SAP

•Met scheduling deadlines for production

EDUCATION

09/05 – 06/09 University of California, Davis B.S. Biochemistry & Molecular, Cellular Biology

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