Sas/Base, Sas/Stat, Sas/Macros, SQL
Resume:
Kun Zheng
************@*****.***
Summary
Advanced knowledge on SAS/Base, SAS/Stat, Macro, SAS/SQL. Proficient in regression analysis, ANCOVA analysis, survival analysis and etc.
Profoundly understanding of CDISC SDTM, ADaM models, and DEFINE.XML. Lead statistical programming work across several projects concurrently, including phase I-III trial, and post-market study.
In-depth knowledge of applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Substantial experience in clinical trial/study of oncology, rheumatoid arthritis, cardiovascular disease, renal impairment, diabetic disease, medical devices, and etc.
Communicate with biostatistician and provide insights of specific project for programming team members.
Setup SAS configuration and start-up options. Develop general SAS macros and SAS batch run script on project level for output and/or repetitive procedures.
Produce and maintain specifications for derived datasets based on SAP and generate codings accordingly. Provide data logic check and validation for data management.
Customize TLF style by using SAS/Template and generate output to pdf and/or rtf files through SAS/ODS. Utilize GTL to create figures such as Box Plots, Kaplan Meier Survival Estimates, Scatter Plots, and Bar Chart.
Help and guide team members to perform qualified validation process. Review and deliver outputs. Technical Skills
SAS Skills: SAS/BASE, SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GTL Language: SQL
OS: Windows XP/7/8
Certificate
SAS Certified Base Programmer for SAS 9
SAS Certified Advanced Programmer for SAS 9
CDISC Certified ADaM Theory and Application Certificate Work Experience and Projects
Statistical Programmer II, QuintilesIMS Jul.2016-present Knowledge of statistics, programming and clinical drug development process. Take the role of programming team lead and build bridge of communications between Biostatistician and programmer. Effectively handle multiple tasks and mainly focus on global projects.
Responsibilities:
Working knowledge of Base SAS, SAS/Statistical, SAS Graph and SAS Macro Language.
Estimate programming scope of work and assist in communicating project status.
Setup SAS configuration and start-up options. Develop general SAS macros and SAS batch run script.
Produce and maintain specifications for SDTM/ADaM and generate codings accordingly. Provide data logic check and validation for data management.
Customize TLF style by using SAS/Template and generate output to pdf and/or rtf files through SAS/ODS.
Utilize GTL to create figures such as Box Plots, Kaplan Meier Survival Estimates, Scatter Plots, and Bar Chart.
Help and guide team members to perform qualified validation process. Review and deliver outputs.
Create DEFINE.XML through openCDISC.
Senior Statistical Programmer, Kuntuo – A Quintiles Company Jun.2015-Jul.2016 Lead programming work of several projects concurrently, from phase I-III trial, and post-market study. Experience in Oncology, Diabetic disease, cardiovascular disease, kidney disease, medical devices, and etc. Responsibilities:
Review CRF and Provide data logic check and validation for data management.
Produce and maintain specifications for safety analysis and efficacy analysis datasets based on SAP and generate derived datasets.
Setup SAS configuration and start-up options. Develop general SAS macros on project level for output and/or repetitive procedures.
Assign programming work of TLF production and validation to team member and provide SAS technical support. SAS Programmer, Northwindsor, Inc. Oct.2014-Mar.2015
According to the data mapping, selected and extracted samples from a list of raw dataset, eliminated duplicates, created a one-subject-per-row dataset with PROC SQL.
With given requirement, established segmentation for the behavior of customer with PROC FORMAT based on their credit score. Applied this segmentation on all selected samples.
Defined new variables and assigned different designated values to them based on campaign matrix using CASE expression in PROC SQL, derived product information for each customer.
For all numeric variables, performed data quality check with PROC MEANS and PROC FREQ, focusing on minimum, maximum, and missing values. Did correction for errors and marked missing value.
With PROC UNIVARIATE, checked extreme values for the dataset and did correction to the errors.
For all character variables, checked data quality with PROC FREQ. Found invalid and missing values. Corrected invalid values and assigned supposed value to the missing ones.
Created a format to separate valid data from invalid data with PROC FORMAT. Applied this format to the whole dataset.
Quality Assistant, AIE Pharmaceutical Inc. Jul.2013-Sep.2014
Planning production schedules on weekly basis. Completed over 30 products monthly on average.
Overseeing production operators, including training, periodic performance reviews and day-to-day supervision.
Participating in new product development based on customer need.
Knowledge of FDA regulations and cGMP. Periodically review and modify Company & Equipment SOPs to provide guidance and ensure safety for all personnel.
Managing inventory to prevent missing and loss through production.
Performing lab test for finishing products, including FTIR and UV-Vis spectroscopy. Approving Certificate of Analysis for every finishing product.
Investigating quality issues and resolving customer complaint.
Handling finishing products shipment.
SAS Project, Clemson Experimental Statistical Class Jan.2013-May.2013 Conduct a survey in school examining a hypothesis if there are differences of the scores between male and female students, and investigating the relationship between study time and exam score. Responsibilities:
Designed and conducted survey in school library. Input survey results into excel file. Using PROC IMPORT step to generate SAS datasets from excel file.
Organized SAS datasets according to descending exam score with PROC SORT step.
Calculated means, standard deviations, and variances of variable exam score and study time with PROC UNIVARIATE step.
Based on hypothesis there is difference of score between male and female students. Ran t-test on SAS with PROC TTEST step. The result showed p-value greater than 0.5 and hypothesis rejected.
Presented score-time relation chart with PRCO GPLOT step.
Based on score-time chart, using PROC CORR to determine the correlation between score and time.
Developed a model between score and time with PROC REG function and checked the model assumption: if score range is normal distribution with PROC UNIVARIATE fuction. Laboratory Assistant, Clemson Bioengineering Department Sep.2011-May.2013
Focused research on co-culture application between macrophages and smooth muscle cells (SMCs) in atherosclerotic calcification: using multiple models (Transwell, directly contact, conditioned medium) co-culturing SMCs and macrophages, extracting DNA, designing primer for genes (TNF-α, Runx2, and etc.), and gel electrophoresis. Analyzed the roles of SMCs and macrophages and their interactions in the cardiovascular disease according to related genes expression. Established thorough co-culture methods to conduct research and finished a thesis of this area.
Major focused on tissue engineer &biomaterial. Had experience in both labs and acquired basic skills to perform most cell tissue experiments. Curriculums included biomechanics, transportation, and statistics, etc. Education
MS in Bioengineering, Clemson University, Clemson, South Carolina BS in Bioengineering, Chongqing University, Chongqing, China
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