Biostatistician
Resume:
No Kang (Robin) Myung
********@***.*** (Green Card Holder)
Summary .
A biostatistician/statistical programmer for 3 years to provide statistical and programming supports to projects in a medical device company.
Strong experience in R and SAS/BASE, SAS/STAT, SAS/MACRO, SAS/GRAPH, SQL
Strong understanding in clinical study life cycles from protocol, SAP, Analysis Data Specification, Analysis Datasets to TFL.
Sample Size Calculation using SAS Proc Power.
Work Experience .
Biostatistician
Syneos Health/Roche Tissue Diagnostics - Ventana Medical Systems, Inc. Oro Valley, AZ
Mar 2015 to Present
Projects
●Serve as biostatistician advisor to project teams during the early phase development studies that are in support of immunohistochemistry (IHC) or in situ hybridization (ISH) assay of in vitro device (IVD) in renal, lung, & bladder cancers.
●Participate in the creation of clinical reports of sample characteristics, subject baseline, and analysis population in relation with pharmaceutical companies using SDTM & ADAM for FDA approval.
●Contribute to the data analysis (Integrated reports) used for the successfully FDA approval for VENTANA PD-L1(SP142) Assay to support immunotherapy treatment decisions in lung cancer.
Responsibilities
●Perform data analysis and prepare statistical reports.
●Perform programming validation & Quality Control (QC).
●Conduct randomization schedules and blinding of samples.
●Perform ad-hoc reports as requested and check data quality of SDTM & ADAM.
●Create Analysis Data Spec based on study analysis.
●Interact with research personnel in development and clinical research projects to ascertain needs and develop appropriate study design and statistical solutions.
●Review and prepare Statistical Analysis Plans (SAPs) and study protocols for use by internal and external customers.
●Meets timelines on a regular basis.
Statistical Programming & Analyses
●Provide data review, manipulation, and programming using SAS PROCs (freq, univariate, SQL, transpose, sort, & format), and various types of merging of datasets (SQL & SAS data step).
●Provide statistical analyses with multiple linear, logistic, Cox regression, and Log-rank test.
●Produce TFL using ODS and PROC REPORT.
●Build SAS Macro for efficient programming process.
Regulation
●Knowledge of good clinical practice (GCP).
Research Assistant - USC Norris Cancer Center, Los Angeles, CA
Oct 2014 to Feb 2015
●Analyzed Phase I & II studies with reports of toxicity summaries & adverse events.
●Used SAS LIFETEST and PHREG to perform Kaplan-Meier analysis with Log-Rank test and Cox regression.
Sep 2012 to Feb 2015
●Performed quality assurance of meta-analyses of testicular cancer using SAS.
●Conducted literature review in case-control studies of testicular cancer with PROC LOGISTIC.
May 2010 to May 2011
●Used SAS and R to conduct data management of melanoma data
●Created daily and monthly figures of sun exposure data using SAS GPLOT.
Jan 2010 to May 2010
●Managed clinical data of Hispanic youth in Excel file.
Certifications .
1.SAS BASE Programmer for SAS 9 Credential
2.SAS ADVANCED Programmer for SAS 9 Credential
3.SAS STATISTICAL BUSINESS ANALYST for SAS 9 Credential
Education .
University of Southern California – Los Angeles, CA
●Master of Science in Biostatistics, May 2014
University of California, Los Angeles – Los Angeles, CA
●Master of Science in Statistics, June 2009
●Bachelor of Science in Mathematics/Economics (Cum Laude), June 2007
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