SAS Programmer
Resume:
Larry P. Apuzzo
East Haven, Connecticut
Home Phone: 203-***-**** / Cell Phone: 517-***-**** *********@*******.***
PROFESSIONAL SUMMARY
Skilled SAS Programmer with extensive Oncology experience in pharmaceutical industry. Familiar with SDTM/ADaM data including Pinnacle 21. Developed and enhanced SAS programs and macros to create derived datasets, report tables, listings, graphs and other output. Wrote and reviewed programming specifications. Familiar with SAP, study protocols, data presentation plans and other documents. Proven ability to work independently and within team environments. PROFESSIONAL EXPERIENCE
IQVIA August 2018 – April 2023
Statistical Programmer - remote
• Worked on Phase I, II and III oncology and immunology clinical trials.
• Annotated Case Report Forms (aCRF) to map raw data to SDTM data sets.
• Programmed for SDTM and ADaM datasets for QC and production. Worked on specifications - manually and by using in- house tools. This required input from CDISC standards, client standards, Controlled Terminology and other documents.
• Programmed for safety and efficacy Tables, Listings and Figures using Statistical Analysis Plans, study protocols, annotated table templates (shells) for QC and production.
• Performed validations on results – including using Pinnacle 21 output to address SDTM/ADaM data issues. Documented findings per company standards.
• Understood programming scope of work, estimated work completed and communicated work status.
• Used and promoted the use of established standards, SOP and best practices.
• Familiar with and utilize Good Programming Practices (GPP) and ICH guidelines. Micro-Tech Computer Services Incorporated (Weatogue, CT) October 2011 – August 2016 Consulting firm working under Eliassen / eClinical Solutions
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Position: Senior Programmer - contractor
• Worked with team to evaluate existing programs undergoing modifications due to data migration to deliver BDR (Blinded Data Review) report and to address queries from European review committee.
• Worked in team environments performing quality control by writing and modifying peer code for safety and efficacy analyses per request. These included demography, adverse events, descriptive statistics, normal approximations and ad-hoc tables, listings and graphs.
• Performed Peer Review / Peer Testing for programs/macros to create ADaM structured data sets according to specifications. Included use of in-house CDISC Validator.
• Created several ad-hoc tables and listings by pooling data from three studies for request from ASH (American Society of Hematology) for Prior Chemotherapy regimens based on specified subject groups. Received favorable review from Pfizer statistician.
• Wrote new program which compared CRF-entered values to calculated values (for IPI / FLIPI – International Prognosis Index / Follicular Lymphoma IPI). This required quick understanding of these variables and their derivations.
• Performed QC and worked on ad-hoc requests for reports to EHA (European Hematology Association).
• Received Pfizer Certificate of Achievement for contributing to exceeding 2011 quality and speed goals in support of Pfizer DevOps (Development Operations).
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Larry Apuzzo (continued)
BRISTOL-MYERS SQUIBB - Wallingford, CT May 1997 – June 2011
(A global biopharmaceutical development and manufacturing company.) Position: Principal Analyst I
Primarily supported Oncology and Immunology research groups. Interfaced with Data Management, Biostatistics, Clinical Research, Medical Writers, Drug Supply, and Regulatory departments. Programmed for a wide variety of tasks in Phase I, II and III studies including: Clinical Study Reports (CSR) with electronic submissions, Investigator Brochures, Annual Investigational New Drug (IND) Reports, Clinical Safety Summaries, Data Monitoring Committee (DMC) Reports, ad-hoc reports, and data edit checks. Worked with data collected in-house and from outside agencies. Other responsibilities included: familiarization and understanding of study protocols, and statistical analysis plans; programming validation and documentation.
• Oversaw closing of two Phase I oncology studies working with contract programmers. Furnished derived database, programming documentation, and provided all output as required by Biostatistics and Clinical groups. Facilitated and assisted in validation of all programming output. Ensured all deliverables were presented on schedule.
• Initiated learning HTML by attending in-house class. Applied HTML to create SAS output viewable in browser with embedded links to CRF imaging system, giving users direct access to specific pages related to edit check output. Attended in-house Excel Visual Basic class.
• Worked with members from Drug Supply to develop batch listings for Oncology report. Required writing program to pull data from Excel files to match against SAS data and handling mismatches according to specifications as edit checks.
• Functioned as primary programmer throughout entire supplemental New Drug Application (sNDA) process for TAXOL involving data from outside vendor (SWOG – Southwest Oncology Group). Supported manual annotation of case report forms (CRF), wrote early data analysis programs and clinical study report programs. Programmed to answer questions presented by FDA, and wrote database documentation in accordance with regulatory guidelines. Attended presentation of study report to Oncology Drug Approval Committee (ODAC).
• Contributed as team member toward development, maintenance, and documentation of system that produced standard Investigation of New Drug (IND) reports. This system accommodated data that varied in structure between studies and therapeutic areas to produce standard reports in accordance with standard operating procedures (SOP) based on FDA guidelines.
• Selected to attend various professional conferences including SAS User Group Conferences (PharmaSUG conferences, Boston MA 2001 and Denver CO 2007). Presented at Hartford Area SAS User Group (HASUG) n 2004.
• Attended several in-house and off-site SAS courses (including Proc Report, ODS, and SQL). PROFESSIONAL ASSOCIATIONS
Hartford Area SAS User Group (HASUG)
EDUCATION
SAS EDUCATION: Accrued 9.2 C.E.U. points from SAS Institute since 1998 B.S., Computer Science – University of New Haven, West Haven, CT Minor: Mathematics
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