For a Big Pharmaceutical  – Mapped Data TO CDISC SDTM Standards

  • Integrated data from multiple systems and converted over 200
    studies to SDTM.

  • QC and Validation of other vendors’ work.

  • Thorough documentation of transformations.

For a
Big Pharmaceutical – Data Warehousing and Data Mart

  • Parsed through multiple legacy systems to gather information for the
    staging area.

  • Interviewed data owners from multiple legacies (acquired via M&A) to
    identify data locations.

  • Built algorithms for transformations.

For a
Mid Size Pharmaceutical - Tables, Listings and Graphs (TLG)
Bonus Feature: A Graphical User Interface (GUI)

  • Under tight deadlines, produced tables, listings and graphs for
    multiple studies.

  • Authored supporting documentation.

  • Preliminary version  of a Graphical User Interface to produce study
    tables, listings and graphs

  • Participated in weekly in-person meetings for specifications,
    clarifications and progression of tasks.

For a
Small Sized  Speciality Pharmaceutical - Tables, Listings and
Graphs (TLG)

  • Under tight deadlines, produced tables, listings and graphs for
    multiple studies.

  • Participated in regular meetings for specifications, clarifications and
    progression of tasks.

For a
Small CROPatient Profiles System and Ad Hoc Tables for Product
Defense

  • Developed a complete patient profile system - capable of parsing
    data from multiple studies and presenting patient level information in
    an organized, logical and user friendly manner.

  • Authored detailed technical specification documentation.

  • Reworked tables and listings to present data in a more organized
    way to defend a NDA filing.  
Projects