Senior Principal Statistical Programmer (SAS/CDISC)

Yingqing (Lindy) Huang

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

West Roxbury, MA 02132

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

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

Professional Summary

• 11+ years of database management, SAS programming, and statistical analysis in clinical trials.

• Received “Recognizing Excellence” award for NDA database lock (July 2016).

• Skilled in CDISC SDTM/ADaM mapping across multiple studies and therapeutic areas (oncology, rare diseases, autoimmune, metabolic).

• Experienced in generating statistical analysis reports, listings, and graphs for Phases I–IV trials.

• Proficient in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, and UNIX environment.

• Expert at developing and debugging macros for data access, extraction, transformation, merging, and analysis.

Skills

• SAS: BASE, MACRO, STAT, SQL, GRAPH, CONNECT, Enterprise Guide

• CDISC: SDTM, ADaM, Define-XML, Pinnacle 21 Validation

• Clinical: TLF Generation, Data QC/Validation, FDA Submissions, Oncology/Rare Disease/Autoimmune/Metabolic

• Automation: Custom Macros for Extraction, Transformation, Merging

• Tools: Medidata Rave, Oracle Clinical

• Programming Languages: SAS, SAS Grid environment with SAS Enterprise Guide, R, C/C++, JAVA, C#. Perl, TCL script Language

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

• Other: GCP/ICH Compliance, Data Cleaning, Reconciliation, FTP, SSH, PUTTY, and Xming. Toad.WinSCP and GPSII

Experience

SKY Pharmaceutical Development, 66 High Ridge Rd Skillman, NJ, 08558-2374 Jun 2025 – Present

Senior Principal Statistical Programmer

• Led SDTM/ADaM specification development and TFL generation for IIT-IH study, ensuring CDISC compliance and timely FDA submissions.

• Built/validated pivotal datasets and updated specifications; Delivered safety/efficacy tables, listings, figures for DSMB reviews

• Mapped ADaM with KASA-1, KASA-3, KASA-5, KYSA-6 and KYSA-8 trials for integrated safety/efficacy analysis. Delivered high-quality TFLs for ISS/ISE.

• Programmed reusable macros for data processing and QC.

Therapeutic Areas:

1. Autoimmune diseases: Myasthenia Gavia (KYSA-6 Phase II/ III), Lupus Nephritis (Phase I/ II KYSA-1, KYSA-3), Stiff Person Syndromes (KYSA-8 Phase II)

Clinvia LLC, 2500 Regency Pkwy, Cary, NC 27518 May 2024 – Jun 2025

Senior Principal Statistical Programmer

• Directed team of programmers on CRO deliverables, ADaM datasets creation and validation; coordinated with biostats and data management for FDA-compliant outputs.

• Developed key macros for TLFs across studies; reviewed submissions, fixed QC issues.

• Oversaw quality control: validated code/output from peers, ensured consistency and accuracy in high-volume datasets.

• Generated tables, listings, and figures for Development Safety Update Reports (DSUR), Investigator’s Brochure (IB), and safety monitoring committee (SMC) updates as requested.

Therapeutic Areas:

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).

Covance, Durham, North Carolina Oct 2020 – May 2024

Senior Statistical Programmer

• Developed SAS programs for SDTM/ADaM datasets, patient profiles, TLFs, and integrated summaries (ISS/ISE) in support of clinical studies.

• Led programming for AstraZeneca projects: created ADaM specs, QC’d ADLB/ADEFF/ADTTE/ADTR/ADPC/ADPP datasets for endometrial cancer and chronic kidney disease studies.

• Generated ADaM datasets, TLFs, and macros for B-cell lymphoma interim analysis; used PROC MIXED for efficacy endpoints.

• Reviewed SAPs, annotated CRFs, produced Define.xml, and performed QC on datasets/outputs for accuracy and CDISC compliance.

• Oversaw workload for junior programmers; coordinated with Clinical Data Management, Project Management, and Medical Writing teams.

• Advised on technical solutions, reviewed drafts/changes to ensure timely, high-quality deliverables.

Therapeutic Areas:

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), Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) (Phase I).

2.Chronic Kidney Disease and Hyperuricemia (Phase IIb).

3.WHO Group 1 Pulmonary Arterial Hypertension (PAH) (Phase II), Atrial Fibrillation (Phase II2b), Chronic heart Failure (Phase II).

4.NASH Cirrhosis (Phase II2b/3), Hemophilia A.

5.Other: COVID-19 infection (Phase II/ III).

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

Senior Statistical Programmer

• Developed standard operating procedures and user guides for statistical programming; established standardized program file folders to streamline workflows.

• Led programming efforts for Phase II trials, Investigator’s Brochure (IB), DSURs, Integrated Summary of Safety (ISS), and annual safety reports.

• Created and maintained analysis macros; collaborated with medical monitors, clinical data management, and biostatisticians to meet FDA and company standards.

• Generated and reviewed TFL shells; produced SDTM and ADaM specifications; delivered programs and datasets for EHA and ASH annual meetings, including CGVHD study data.

• Provided rapid-response programming support for urgent FDA and cross-functional team requests.

• Built programs for data cleaning, edit checks, and ad-hoc tables/listings/figures; validated TFLs for publications, IND submissions, DSURs, and investigator brochures.

• Oversaw CRO deliverables; performed QC on SDTM/ADaM datasets, Define.xml files, and user guides; resolved emerging issues in real-time.

Therapeutic Areas:

1.Non-Inflammatory Immunology - Graft vs. Host (Phase II), Systemic Sclerosis (Phase I, II).

2.Immuno-oncology (Phase I)

Agios Pharmaceuticals, Cambridge, MA May 2017 – Nov 2017

Contract Statistical Programmer

• Developed and validated ADaM/SDTM datasets across multiple projects; ensured full compliance with ADaM/SDTM implementation specifications.

• Converted PC/PP specs into SAS code; generated ADaM datasets, tables, listings, figures (TLFs) for PK/PD analysis.

• Built statistical programs for ad-hoc reports, internal/external requests; maintained/upgraded outputs on demand.

Therapeutic Areas:

1.Hematologic Malignancies: Leukemia (Phase I, II)

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

Premier Research, Quincy, MA Feb 2016 - Mar 2017

Senior Statistical Programmer

• Led programming support for two oncology studies; developed patient profiles, supported data management on complex checks.

• Built/tested programs for detailed analyses per SAP; supervised/validated TLFs for safety/efficacy in IND/NDA submissions.

• Performed QC on integrated code/outputs from other programmers; prepared ADaM datasets for ISS/ISE.

• Delivered lead programming for biometrics macros; documented SAS programs and management processes.

Therapeutic Areas:

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 for clinical data cleaning, validation, analysis, and report generation.

• Supported SAS code development for oncology datasets; ensured accurate summaries for trials.

Therapeutic Areas:

1.Solid Tumors: Colorectal Cancer (Phase Ib/II).

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

Statistical Programmer (Consultant)

• Created SAS macros for data manipulation, analysis diagnostics, and GPSII output in clinical environments.

• Developed/validated protocols for edit checks, data management, and compliance; coordinated with Clinical Data Managers.

• Generated tables, listings, figures per SAP; documented outputs for oncology trials—focused on accuracy and speed.

Therapeutic Areas:

1.Solid Tumors: Breast Cancer (Phase I), Leukemia (Phase I).

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

Clinical Data Analyst /SAS programmer

• Developed, modified, and validated SAS programs for statistical analysis and reporting; generated custom safety/efficacy reports in RTF/HTML per SAP.

• Created and updated ADaM/SDTM datasets across multiple projects; ensured compliance with specifications and integrated data from Excel, Access, and Oracle.

• Performed ad-hoc analyses, produced tables, listings, graphs, and monthly reports using SAS macros.

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

SAS Programmer/ Analyst

• Extracted and integrated public health data from diverse sources (Excel, Access, Oracle); designed specs for standard/ad-hoc quality checks on survey datasets.

• Developed SAS macros for census survey analysis, multivariate regression, data modeling; generated tables, listings, graphs, and export files.

• Performed data validation, testing, and coding schemes (ICD-9/ICD-10); supported staff on programming issues and external analysis requests.

Focus: Public Health Surveillance, Survey Data, Multivariate Statistics

Education

• Master’s Degree in Computer Science, Boston University, Boston, MA

• MD in Hygiene, LiuZhou Medical University, China

•SAS Programming & Statistical Training, Harvard School of Public Health

• SAS Certified Base Programmer

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