Experience

Transcenta

• China
• Biotechnology Research
• 1 - 100 Employee

• Consultant at Transcenta

  • Jul 2022 - Present

• Ex. Director, Clinical DM and Statistical Programming

  • Dec 2019 - Jul 2022

  Sr. Director from 12/2019 to 07/2021.



CR Medicon US, Inc.

• Director, Statistical Programming

  • Aug 2018 - Nov 2019

  • As a lead in US to support company IT team in purchasing servers, locating a data center, and setting up server system and network. • Building a statistical programming team to support statistical analyses, including SDTM, ADaM, and TLF development. • Leading a team to develop standard programming templates to increase productivity and efficiency. • Developed a company-wide SAS macro to combine multiple PDF outputs with bookmarks • As a lead in US to support company IT team in purchasing servers, locating a data center, and setting up server system and network. • Building a statistical programming team to support statistical analyses, including SDTM, ADaM, and TLF development. • Leading a team to develop standard programming templates to increase productivity and efficiency. • Developed a company-wide SAS macro to combine multiple PDF outputs with bookmarks



Celgene

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Principal Statistical Programmer

  • Oct 2013 - May 2018

  • As a lead in US to support company IT team in purchasing servers, locating a data center, and setting up server system and network.• Building a statistical programming team to support statistical analyses, including SDTM, ADaM, and TLF development.• Developed a company-wide SAS macro that could combine multiple PDF output files with bookmarks• Helped and supported new employees/contractors SAS environment training and study access management.

• Principal Statistical Programmer

  • Apr 2011 - Oct 2013

• Principal Clinical Programmer

  • Jan 2009 - Apr 2011

  • Led SAS Dataset Post Processing initiative, which created a desktop procedure for post processing EDC data.• Developed standard SAS programs/macros for CDRP (Clinical Data Review Plan) listings; provided training to other Clinical programmers on CDRP programming; maintaining CDRP standard programs.• Participated in JReview validation; provided JReview training to Celgene JReview users; supporting and managing JReview system including user admin, study registration, issue debug, etc.• Worked closely with Drug Safety group for new DSS file format, and developed standard SAS macro for Clinical Programming group to generate SAE Reconciliation reports; • Developed other standard SAS macros/programs for Clinical Programming group to help in routinely clinical programming tasks.• Led clinical programming support to study conducts, including CRF designs, study database setup and UAT in EDC systems (Phase Forward Inform, Medidata Rave), eCRF dynamics and rules (edit checks), etc.• Worked as Oracle Clinical Admin Show less



Roche Pharmaceuticals

• Brazil
• Personal Care Product Manufacturing
• 1 - 100 Employee

• IT Lead Analyst

  • Jul 2007 - Jan 2009

  • Worked with study team, reviewed CRFs, annotated CRFs, created study database document, and setup O/C study database • Programmed OC Derivation and Validation procedures with PL/SQL custom codes. • Developed Excel macros using Visual Basic to extract and compare data in MS Excel sheets. • Programmed in SAS to generate study batch jobs reports, compare study database setup, etc. • Contributed to Roche EDC Next Generation project, and composed test scripts for Medidata Rave performance testing. Show less



Medarex

• Biotechnology Research
• 1 - 100 Employee

• Sr. Clinical Programmer

  • Feb 2002 - Jul 2007

  • Generated Data Management activities reports and data listings by SAS from Oracle Clinical back-end database, for example, CRF missing page report, CRF last page report, Query status report, etc. • Contributed to developing and maintaining department SAS Macro libraries and SAS template programs. • Annotated CRFs, created data specification documents and page matrixes, reviewed validation manual (edit checks), Setup Oracle Clinical studies, developed and maintained Oracle Clinical Validation and Derivation procedures, prepared external data files and batch loaded external data to Oracle Clinical, etc. • Created, setup and maintained the Global library, domains, questions, question groups, Question sets, DVGs. • Participated in system validation and testing of Oracle Clinical and related applications. Show less