Yingqing (Lindy) Huang

** ******* **.

West Roxbury, MA 02132

Telephone 617-***-****(cell)

E-mail: adfsr5@r.postjobfree.com

Summary

More than 7 years of data management, programming, and statistical analysis experience with SAS systems.

SAS Certified Base Programmer for SAS 9.

Won the "Recognizing Excellence award" for the NDA NOVA database lock in July 2016.

Experienced in rare disease and oncology therapeutic areas. Experienced in Phases I, II, III study.

Experienced in statistical analysis, generated reports, listings and graphs for all phases of clinical drug trials studies.

Expertise experience with CDISC SDTM / ADAM mapping (multiple studies and multiple therapeutic areas).

Experienced with SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH and SAS/ODS in windows and UNIX environment.

Proficient in developing and debugging MACROS to access, extract, modify, merge, and analyze clinical data.

Computer skills

SAS Products: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS/ODS, SAS/GRAPH, SAS/CONNECT.

Programming Languages: SAS, C/C++, JAVA, C#.Perl, TCL script Language

Operating Systems: SUN SOLARIS UNIX, LINUX, Windows 98/2000/NT/XP

Databases: Oracle, Medidata RAVE, MS ACCESS

MS Office: WORD, POWERPOINT, EXCEL, and ACCESS

Others: FTP, SSH, PUTTY, and Xming. Toad.WinSCP, GPSII, Clearcase

Education

Masters in Computer Science, Boston University, MA.

LiuZhou Medical School, in China.

SAS programming and statistical training, Harvard school of Public Health.

Experience

Kadmon, Corporation, LLC. Cambridge, MA July 2018 – June 2020

Senior Statistical programmer

Develop standard operating procedure for statistical programming. Create User Guider for creating statistical program file folders.

Work with the medical monitor, biostatisticians to develop/review TFL shells. Generate SDTM and ADaM specifications in collaboration with biostatisticians.

Provide program support for the presentation of EHA and ASH annual meetings. Produce programs to explore CGVHD study data.

Provide quick statistical programming supports for requiring from FDA and other teams.

Create the program to create table, listing and graph for data cleaning, edit check and Ad-hoc requires. Validate and produce TFLs for publications, IND annual reports/DSUR, and Investigator Brochures.

Generate program to perform quality checks for the NDA submission package for KD025 in cGVHD that was delivered from contract research organizations (CROs).

Oversee statistical programming delivery of TFLs by vendors for kd025 and other studies with TFL development to meet reporting requirements

Work closely with the manager, our team members and other teams to discuss issues. Figure out solutions for new-finding problems.

Agios Pharmaceuticals, Cambridge, MA Apr 2017 – Nov 2017

Contract Statistical programmer

Developed SAS program to create and validate ADAM/SDTM datasets on multiple projects. Ensured that ADAM/SDTM datasets with respect to ADAM/SDTM implementation are ADAM/SDTM –compliant. Provided input as needed on ADAM/SDTM implementation. Developed, maintained and updated ADAM/SDTM specifications.

Converted specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.

Validated datasets and Tables, Listings, and Figures for clinical trials data.

Developed statistical programs for ad-hoc reports, and other internal and external requests.

Trained junior level programmers.

Premier Research, Quincy, MA Feb 2016 to Apr 2017

Senior Statistical programmer

Provided lead programming support to two clinical studies.

Developed Patient Profile, supported data management team to do data check.

Developed and tested programs to complete complex analyses identified in statistical analysis plans with no supervision.

Developed and validated tables, listings and graphs for specific projects and project shells in the biostatistics department.

Developed and tested programs to complete quality control and validation work generated by other programmers.

Provided programming support for integrated summaries of safety and efficacy for IND and NDA submission.

Developed the program to create SDTM/ADAM datasets on multiple projects.

Provided lead programming support to Biometrics or specialized data analysis requirements, as assigned.

Provided support for the maintenance and management of the biostatistics macro library.

Prepared documents to describe SAS programs as assigned. Trained junior level programmers.

Boston Biomedical Inc., Cambridge, MA Apr 2015 – Oct 2015

Senior Statistical programmer (Consultant)

Created SAS Macros to develop SAS Programs for clinical data cleaning, validation, analysis and report generation.

Developed SAS program to create ADAM/SDTM datasets.

Performed statistical analysis, generated reports, listings and graphs for all phases of clinical drug trials studies.

Designed specs and programs to provide standard and ad hoc data quality checks across all studies.

Implemented QC programs for validation of TLFs and datasets. Performed SAS edit-checks.

Novartis Institute for Biomedical Research Inc., Cambridge, MA Feb 2014 – Apr 2015

Statistical programmer (Consultant)

Developed SAS macros code to get data, manipulate data, and create table statistics and present output in formats specified in protocols for preparing, processing, and analyzing diagnostics and clinical data in GPSII environment.

Developed and implemented statistical programming specifications and code testing plans with statisticians to assure high quality of developed programs and analysis output and to meet compliance requirements.

Identified and carried out edit checks per data validation or data management plans.

Met with SAS Developer/biostatisticians/Clinical Data Coordinator/ Clinical Data Manager/ Clinical Research Coordinator for clinical trial protocol reviewing, Statistical Analysis Plan reviewing.

Generate tables, listings, figures, and analysis datasets and to carry out required statistical analysis according to protocol by creating production output in Clearcase.

Documented developed code, or other documents in required format and location by protocol.

Developed, modified, validated and implemented SAS programming according to Statistical Analysis Plan (SAP).

Written custom safety and efficacy reports directing SAS output to RTF and HTML files using ODS.

Fresenius Medical Care North America, Waltham, MA Aug 2013 – Feb 2014

Clinical Data Analyst /SAS programmer (Consultant)

Wrote code using SAS/Base and SAS/Macros to extract data from Excel file, Access Database, and Oracle database.

Integrated data from different studies for statistical analysis and reporting.

Performed statistical analysis, generated reports, listings and graphs. Produced Ad Hoc reports using SAS.

Developed routine SAS macros to create tables, graphs and listings to produce weekly and monthly reports.

Boston Public Health Commission, Boston, MA Jan 2012 – Aug 2013

SAS programmer/ Analyst

Designed specs and programs to provide standard and ad hoc data quality checks across all studies.

Extracted data from different sources and converts them into SAS datasets. Include large survey datasets and U.S. Census data. Exported data sets to external files.

Performed survey Analysis and Linear Regression including Multivariate Analysis, and Data modeling.

Generated MACRO code to access, extract, modify, merge, and analyze clinical data, and to generate statistical analysis outputs including tables, listings, graphs and reports.

Performed validation, including testing SAS code, coding schemes (ICD-9, ICD-10).

Helped other research staff for programming and analysis issues. Provided analysis data for outside organization.

Nortel Networks, Billerica, MA May 2006 – Dec 2008

Systems test Programmer

Responsible for supporting the research team in production of custom market research projects, specifically in the Communications sphere, with a focus on data analysis. Processed and analyzed survey data in SAS.

Worked closely with the business to identify the business needs/problems and translated those into analytical questions as well as design analytic plans to address business needs/problems.

Used programming skills (SAS and/or SQL) to retrieve and manipulate large datasets and multiple data sources, and execute analytic plans. Interpret analysis and provide the business with relevant and actionable insights, leveraging strong business knowledge to make recommendations to the business.

Used SAS /Graph to make main pages of different divisions of the company and put them on a web portal. Using proc greplay displays two more graphs on one page. Used SAS /Graph annotation skill to draw customer charts. Using ODS html drill down technical link to different URL.

Division of Epidemiology, Epidemic Prevention Station, GuangXi, China Sep 1989 – Feb 1997

Programmer/ Epidemiologist/ Physician

Responsible for study design, organizing field team, training, coordinating of the field work and statistical activities in support of research. Produced publications in Chinese journals.

Developed and implemented statistical programming specifications and code testing plans.

Identified and carried out edit checks per data validation or data management plans.

Performed Data analysis, statistical analysis, generated reports, listings and graphs using SPSS.

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