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 insight from data visualization on a real-time basis so that both Study Execution Team and Executive Leadership Team can make a timely decision and take an immediate action to adjust strategy. Due to the increased demands for the effective review of data and the support of business decision making, Real-Time Analytics + data visualization become a highly recommended strategy for a fast-growing company.• 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 submissions such as DSUR delivery, ESMO delivery and CSR delivery.• 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 datasets packages for multiple projects from Cassiopea Pharmaceutical.• 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. And responsible for peer review of the submission packages.• 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.