Mike (Huimin) Xue
Belle Mead, NJ 08502
** ***** ** ******** ******** experience
Diabetes, Oncology and Inflammation Phase I, II and III experience
5 years of lead data manager experience
10 years of SAS programming experience
10 years of global experience
10 years of experience managing third party vendors (central labs, ECG, biomarker, specialty labs, EDC, IVRS, etc.)
Experience managing 3 studies (same study) from study start up through database lock
5 years of experience programming, testing and writing edit checks
10 years of experience performing SAE, Lab and external reconciliation
Experience writing Trial Validation Plans and Data Flow Plans
5 years of EDC experience (Inform, DataTrak)
5 years of JReview experience
Working experience of CDISC SDTM and ADaM
Novo Nordisk Inc., Princeton, NJ 07/2017 – Present Real world Data Analyst – HEOR (contractor)
Responsible for the data analyses to support HEOR studies and programs
Provide data programming, analytic, and statistical support for the development of Health Economics and Outcomes Research (HEOR) evidence from large health care administrative databases and insurance claim databases.
Optimize SAS programming processes to improve the performance. Kyowa Kirin Pharmaceutical Research Inc., Princeton, NJ 11/2016 – 06/2017 Senior SAS programmer (contractor)
Responsible for validating the analysis datasets and TLFs and supporting clinical study activities
Performed programmatic review of analysis datasets and TLFs generated by statistical vendor, ensured deliverable quality for the studies.
Reviewed Study Date Tabulation Model (SDTM) dataset and Analysis Data Model (ADaM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP.
Provided programming support for the clinical study team by generating and maintaining patient profiles, data review listings and other outputs.
NOVO NORDISK INC., Princeton, NJ 10/2006 – 10/2016 Leading global healthcare company
Principal Clinical Data Analyst (12/2012 – Present) Senior Database Analyst (5/2008 – 12/2012)
Database Analyst (10/2006 – 5/2008)
Responsible for the support of assigned clinical trials and business related projects. Close collaboration with other members within Clinical Trial Management (CTM) and global trial team.
Conducts the SAE/MESI data reconciliation to ensure that data between OC and Argus are matched.
Designed and developed SAS programs for created titration report package which includes various graphs, tabulates, and reports for physicians to quickly and easily review patient’s titration data.
Created and implemented SAS program to analyze data from time sheet and generate summary reports, by which upper management made decision to optimize the resource for different groups within Clinical Trial Management.
Implemented SAS program to generate over 200 graphs and reports for over 40 trials in order to support the diversity project.
Generated data review listing, summary report, and Graphic Patient Profile in JReview.
Programed oracle clinical edit checks in PL/SQL.
Accountable for the quality and maintenance of clinical data management system (OC, Inform EDC) in accordance with NNI SOPs.
Perform ongoing data cleaning and review to assure quality of the data and compliance with NNI SOPs, GCP and ICH Guidelines, and Federal regulations.
Support the design and development of CRF, validations, and clinical database for phase I, II and III studies.
Provide quality overviews and consistent checks on all clinical data and DM trial documents.
Manage the relationship with clinical research monitors, database programmers, statisticians, clinicians, trials managers, and other team members for trial progress.
Prepare the trial validation plan (edit check, manual check, etc.) and manage the timeline of data management activities.
Lead and manage a large trial with patient population over 8000.
Create, maintain, and file various data management documents for clinical trials.
Assists the project team in preparation for audits/inspections and provide support. MEMORIAL SLOAN-KETTERING CANCER CENTER, New York, NY 10/2000 – 10/2006 World’s oldest and largest private cancer center
Senior Application Analyst (10/2002 – 10/2006)
Application Analyst (10/2000 – 10/2002)
Designed and developed customized database application for Clinical Research Database (CRDB) and built PL/SQL stored procedures for data transfer.
Designed and implemented laboratory system, which included registering specimens and performing standard operation procedures, and validated the process.
Implemented the Specimen Tracking System which tracked a specimen from its initial stage, to the stage of being partitioned into multiple units stored in the specimen bank, to distributed specimen.
Enhanced real-time TCP/IP socket server programs which processed lab test data with HL7 data format.
Implemented PL/SQL program to exchange clinical data in two different companies’ computer systems.
Developed PL/SQL store procedure to transfer surgical data into Clinical Research Database.
M.S., Computer and Information Science
New Jersey Institute of Technology, Newark, NJ
JReview Core Concepts/Advance topics Certification
Advanced Project Management courses
SAS Certified Advanced Programmer for SAS 9
SAS SQL Training
TRAINING AND CERTIFICATIONS