Data Management Clinical

Yingqing (Lindy) Huang

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

West Roxbury, MA 02132

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

E-mail: **********@*****.***

Summary

** **** ***** ** **** 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 clinical trial therapeutic areas in Phase I, Phase II & Phase III.

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) and TFLs.

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

Master’s degree in computer science, Boston University, MA.

MD in Hygiene, LiuZhou Medical School, LiuZhou, Guangxi/ LiuZhou /China.

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

Experience

Biomea Fusion Inc, 900 Middlefield Rd, Redwood City, CA 94063 May 2024– Present

Senior Principal Statistical Programmer

Leading a team of statistical programmers. Coordinated with clinical data management and biostatisticians, overseeing CRO deliverables, and ensuring compliance with FDA regulations and company standards

Provided programming expertise to support clinical trials and regulatory submissions, ensuring high-quality data management and analysis.

Created key macros ad hoc TLFs across studies. Develop specifications for ADAM datasets. Develop and maintain SAS programs to create ADAM datasets and TFLs.

Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group.

Develop tables and listings for the development safety update report (DSUR), Investigator’s Brochure (IB), and safety monitoring committee (SMC).

Perform other duties as requested by management.

Therapeutic Experience:

1--Oncology: acute leukemia (wild-type FLT3 AML, ALL, or MPAL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PDAC), and Colorectal Cancer (CRC).

2-- metabolic disease: Type 1 and 2ype 2 Diabetes Mellitus (Phase I/ II).

Fortrea (Formerly Labcorp), Durham, North Carolina May 2023– May 2024

Senior Statistical Programmer

Perform the role of the Lead Statistical Programmer

Develop and maintain SAS programs to create SDTM and ADAM datasets and TFLs, and perform QC of SDTM, ADAMs and TFLs

Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADAMs

Develop specifications for SDTMs and ADAM datasets.

Review SAPs and TFL shells from a programming perspective for studies

Perform other duties as requested by management.

Therapeutic Experience:

1--Oncology: acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

2--NASH Cirrhosis, Hemophilia A.

Covance (Acquired by Fortrea), Durham, North Carolina Oct 2020 – May 2023

Senior Statistical Programmer

Develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables,

Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of

Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).

Act as a Lead Programmer for projects

Write ADAM ADSL, ADLB, ADEFF, ADTTE, ADTR, ADPC and ADPP Spec for AstraZeneca SZ Peds study. QC tables for AstraZeneca late-stage Endometrial Cancer study.

Create ADAM spec, QC SDTM, ADAM and tables for AstraZeneca late-stage Chronic Kidney Disease and Acerta Non-Germinal Center Diffuse Large BCell Lymphoma study.

Review aCRF, SDTM spec to examine the Effects of Study drug in subjects with COVID-19 infection.

Provide technical planning to include overseeing the set-up of key macros and SAS programs

Act as a Statistical Programming consultant to clients and internal customers in related disciplines

e.g. Clinical Data Management, Project Management and Medical Writing.

Prioritize personal workload and that of teammates; perform work with minimal supervision

Work on complex problems where analysis of situations or data requires an evaluation of intangible

Variables, development of technical solutions to abstract problems which require the use of

ingenuity and creativity.

Advise Senior Statistical Programming Staff of changes in scope of projects to enable the timely

development of change orders.

Review draft and final production runs for project to ensure quality and consistency.

Represent Statistical Programming during client audits ensuring study documentation is maintained

and filed according to Covance processes.

Perform other duties as requested by management.

Therapeutic Experience:

1--Oncology: Endometrial Cancer (Phase III), Non-Germinal Center Diffuse Large B Cell Lymphoma (Phase III), Thyroid Cancer and Non-Small Cell Lung Cancer (NSCLC) (Phase I/ II), Advanced B-Cell Malignancies (Phase I).

2--Other: COVID-19 infection (Phase II/ III), Chronic Kidney Disease and Hyperuricemia (Phase IIIb), WHO Group 1 Pulmonary Arterial Hypertension (PAH) (Phase II).

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

Senior Statistical Programmer

Developed standard operating procedure for statistical programming. Created User Guider for creating statistical program file folders.

led statistical programming activities supporting IB, DSUR, Integrated Summary of Safety (ISS), Annual Safety Reports and/or other safety analysis.

Maintained macros, developed programs for data analysis, coordinated with the medical monitor, clinical data management and biostatisticians, overseeing CRO deliverables, and ensuring compliance with FDA regulations and company standards

developed/reviewed TFL shells. Generate SDTM and ADaM specifications in collaboration with biostatisticians.

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

Provided quick statistical programming support for requirements from FDA and other teams.

Created 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.

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

Oversee and QC CRO-development SDTM and ADaM datasets, Define.xml files, and user guides (SDRG, ADRG).

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

Therapeutic Experience: Non-Inflammatory Immunology - Graft vs. Host (Phase II), Systemic Sclerosis (Phase I, II), Immuno-oncology (Phase I)

Agios Pharmaceuticals, Cambridge, MA May 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.

Create use PC and PP datasets and correlated analysis datasets. Create TFLs for PK/PD analysis.

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

Therapeutic Experience Oncology Solid Tumors: Hematologic Malignancies – Leukemia (Phase I, II),

Rare Disorders: Pyruvate Kinase Deficiency - (Phase II).

Premier Research, Quincy, MA Feb 2016 - Mar 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.

Performs quality control checks of SAS code and output produced by other Statistical Programmers.

Provided programming support for integrated summaries of safety and efficacy for IND and NDA submission. Prepared metadata for a study and worked on an ISS or ISE.

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.

Therapeutic Experience: Solid Tumors – Ovarian Cancer (Phase I, II, III), Breast Cancer (Phase II, III).

Boston Biomedical Inc., Cambridge, MA Mar 2015 – Aug 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.

Therapeutic Experience: Colorectal Cancer (Phase Ib/II).

Novartis Institute for Biomedical Research Inc., Cambridge, MA Feb 2014 – Mar 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 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 SAP.

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

Developed SAS program to create and validate ADAM/SDTM datasets on multiple projects. Developed, maintained, and updated ADAM/SDTM specifications.

Therapeutic Experience: Breast Cancer (Phase I), Leukemia (Phase I).

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

Clinical Data Analyst /SAS programmer

Wrote code using SAS and SAS/Macro 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.

Therapeutic Experience: Kidney Disease (Phase I to III).

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 converted 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, Billeric, MA May 2006 – Dec 2008

System Test Programmer

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

Manual test and develop automated test scripts for Ethernet Routing Switch (Passport 8600)

Designed and implemented API for automation tests by using TCL programming Language on UNIX operating system.

Responsible for writing automating programming for test IPv6 protocol. The feature included IPv6 Stateless, ICMPv6, IPv6 static route, IPv6 MLT/SMLT, MTU, ND, QOS

Responsible for testing and automating security test cases for Passport 8600. The features included access policy, SNMPv3, HTTP, SSH, password.

Developed automation for testing Multicast protocol

Developed automation programming for Scalability test.

Manual test and develop automated test scripts for Ethernet Routing Switch (Next Generation Passport

8600, Cob Blue)

Designed and implemented automation test programming by using Java on Linux operating system.

Developed automation programming for testing IPv4 protocol. The feature included ARP, ICMPv4, RIP,

VLAN, Static router.

Developed automation programming for Line Card test.

Analyzed requirements, designed and wrote test plans according to functional and design specifications.

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