- Dynamic and Result - oriented Statistical Programmer with extensive experience covering all aspects of R, Python, SQL & SAS processes - including the generation of tables, listings and graphs (TLGs), the creation of analysis datasets, and the design of specifications according to the protocol, SAP and annotated CRF.
- Well trained in Good Clinical Practice (GCP), Good Manufacture Practice (GMP), Regulatory Compliance and FDA Guidelines.
- Excellent communication, leadership and collaboration skills.
Tools: SAS/Base | SAS/Stat | SAS/Graph | SQL | Python | R | P21 OpenCDISC
Database: Oracle Clinical | SQL Server 2000 | PL/SQL | MS Access
Operating Systems: UNIX WINDOWS MS-DOS
Programs: Microsoft Office Suite (Word, Excel, PowerPoint, Access and Outlook)
- Solid knowledge and excellent experience in FDA regulations, Data Management and Data Analysis.
- Solid knowledge and experience in CDISC to create SDTM and ADaM datasets, and controlled terminologies.
- Very good understanding of R&D, clinical study data and hands on experience in data manipulations, analysis and reporting of analysis results.
- Designs, develop, evaluate and modify R & SAS programs to analyze and evaluate R&D and clinical data
- Meticulously analyzed and validated datasets and outputs using SAS/Base, Stat, ODS, Graph, Macro & SAS/Report. Created formats for the coded data and used SQL for data validation
- Work collaboratively with team member in statistical analyses and generating reports
- Render support in generating analysis datasets and creating specified structure of TLGs through creating macros and macro variables using advanced SAS & R techniques
- Oversee assay development and manufacture of Bioassay Kits and bioassay service for biological samples.
- Plan, write, and execute protocol focus to assay development and CRO service.
- Industry expertise in providing SAS, Python & R Programming and analysis support for oncology drug screen study
- Provided operational support by creating tables and graphs to produce manufacture inventory reports using excel and SAS, R program
- Develop ELISA assay for oncology pre-clinical trial project(NIH SBIR/STTR grant)
- Develop cell-based reporter assays to monitor HIV Rev-RRE interactions as high-throughput screen method for identifying specific inhibitors of RNA-protein interactions
- Identified small number analogs as anti-HIV compounds (NIH SBIR/STTR grant).
- Using SAS and computer model design anti-HIV drug target sequences
- Screen high affinity RNA binding peptides basing on HIV protein-RNA interaction
- Bioinformatics analysis HIV viral genomic mutation with small molecule drug
- Design RNA-binding proteins, Tat -TAR interaction in HIV viral life cycle