Jerry Berkowitz Email and Phone Number

SDTM table mapping and generation. SDTM macros written to automate data extraction (using high level PROC SQL processing). Special ad-hoc programming for projects with external partners. Maintenance and debugging of macro library. CDISC compliant project, work including submission quality datasets, listings, tables and figures. Created macros to create and update CDISC metadata. Created macros and programs that created analysis data sets and output (Table, listings and graphs) for FDA… Show more SDTM table mapping and generation. SDTM macros written to automate data extraction (using high level PROC SQL processing). Special ad-hoc programming for projects with external partners. Maintenance and debugging of macro library. CDISC compliant project, work including submission quality datasets, listings, tables and figures. Created macros to create and update CDISC metadata. Created macros and programs that created analysis data sets and output (Table, listings and graphs) for FDA submissions. Show less

Manage the duties of 3 permanent and 2 contract programmers. Coordinate Item 11 activities for an NDA. Wrote and modified SOP’s.SAS programming (tables, listings, graphs) in support of Clinical research and NDA submission. Validate and create SAS/MACROS for a standard macro library. Map CRO and old study data into a standard structure.

SAS programming (tables, listings, graphs) in support of Clinical research and BLA submission. Build databases for Oracle/Clinical along with validation checks and extractions into SAS.

Systems support for data management and clinical programming. Use of SAS/FRAME and FSEDIT and SCL language to support a data entry system. Use of PROC REPORT to provide listings. Verify and maintain ORACLE based systems. Programmed retrievals and edit checks. Received Oracle/Clinical, Clintrial and MS/Access training.

SAS programming in support of an NDA, responsibility for implementing the CANDA for certain protocols.

Developed standards in database design and programming. Developed SAS/MACRO programs to automate standard reports (listings, summaries and graphs). Developed query tools by using SAS/ACCESS and the PROC SQL procedure, for direct access to the ORACLE database.