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Manager Advanced/reagents Systems Resume

San, FranciscO

SUMMARY

  • 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.
  • A diligent scientist with more than 9 years of industrial scientific experiences on small molecule anti-HIV drug discovery and immunotherapy cell based bioassay development.
  • More than 10 years of academic scientific experiences on BLV Molecular Pathology and HIV protein-RNA interaction research.

TECHNICAL 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

Web Technologies: HTML, JavaScript

Programs: Microsoft Office Suite (Word, Excel, PowerPoint, Access and Outlook)

Molecular Biology: DNA & RNA isolation, PCR, RT-PCR, RT-qPCR, cloning, sequencing, Gene editing

Cell Biology: Cell culture, Transfection, Constructing stable cell lines, Flow Cytometry Gene

Therapeutic: Primary cell isolation & gene editing,Gene array(microarray), ISH, FISH, Drug screening, Viral transductions

Assay Development: Enzyme kinetics, ELISA, Cell viability/Cytotoxicity assay, Cell based bioassay, Biomarker

Bioinformatics: NCBI/BLAST, Sequence alignment, Gene expression (NGS) analysis, RNA-protein interaction, Protein-Protein interaction

PROFESSIONAL EXPERIENCE

Manager Advanced/Reagents Systems

Confidential

Responsibilities:

  • 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.

Data Scientist

Confidential

Responsibilities:

  • 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)

Scientist Advanced Genetic Systems

Confidential, San Francisco

Responsibilities:

  • 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).

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