Huan M. Email & Phone Number

Alameda, California, US

• RTA means Real-Time Analytics. In this highly competitive market, RTA provides dynamic interactive and integrated data review. Another nice feature in RTA is the data ‘drill-down’ capability which can offer deeper.
• Developed ADS (ADaM-like) datasets specification and generated ADS datasets to support Exelixis real-time analysis (RTA) for early-phase trials.
• Led/supported the development of internal applications/server to generate interactive TFLs dashboards using SAS, R and Tableau.

Sunnyvale, CA, US

• Leaded and Supported ad-hoc analysis request and explore test for PCYC-1137 Phase III project. Provided support in Final TMF Transfer from CRO to sponsor.
• Validated SDTM safety domains for PCYC-1123 Project ACO 2020 DBL.
• Provided comprehensive SAS programming support for PCYC-1128 project. Worked collabora-tively with others to develop and validate ADaM databases, TFL outputs for internal publication and different regulatory.
• Support SAS datasets updating for PCYC-1128 Tableau Dashboards monthly.

San Diego, California, US

• Reviewed key study documents (CRFs, SAP, Datasets Specs, mock TFLs) to ensure alignment with development objectives, clarity and completeness of programming requirements.
• Independently developing, maintaining, and documenting SAS programs in creating ADaM analy-sis datasets and prepare datasets specifications. Creating define.xml and data reviewer’s guide doc-uments (ADRG) for ADaM.
• Performed consistency checks (Pinnacle 21 validation checks) for define.xml against aCRFs and analysis datasets in.xpt format.
• Provided comprehensive SAS programming support for projects from AstraZeneca plc, Hanmi Pharmaceutical, Cosmo Pharmaceutical, etc., including development of programming strategies, standards, specifications in TFLs..
• Developed Macro utility to facilitate the development of TFLs with concise logic flows.

San Diego, California, US

• Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
• Understand clinical trial protocols, aCRF, SAP.
• Worked and communicated closely with Statistician, Qc programmers and upstream Developer (SDTM group) to meet milestones as assigned with high quality for 10+ projects.
• Transforming specifications in SAP into fully documented, validated SAS programs supporting both safety and efficacy displays, and analysis datasets required for clinical study reports.
• Independently testing, maintaining, and documenting programs for use in creating study datasets in statistical tables, figures, and listings.
• Provided supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

Horsham, Pennsylvania, US

• Understand clinical trial protocols, aCRF, SAP.
• Work with statistician lead and programming lead to develop and validate CDISC compliant SDTM and ADaM specification and SAS programs for implement SDTM Mapping and generate ADaM datasets,
• Creating Listing report working with statistician and programming lead.

Implement data transformation and data cleaning; Development and maintenance of SAS datasets; Strategic marketing support using data analysis and data extraction. Statistical analysis and reporting of clients’ inventory and sales data; Customer behavior analysis using statistical models.

• Design SAP (Statistical Analysis Plan) for a 3-year Clinical experiment on VAAFT(Video-Assisted Anal Fistula Treatment). Determine Sample size based on statistical power and significant level.
• Create, modify, update, maintain and query Oracle DB using SQL. Interpret and report the results of the study to supervisor by using SAS/Connect, SAS/SQL, SAS/Stat, SAS/Graph and SAS/ODS.