Larry P. Apuzzo

** ****** ******

East Haven, Connecticut

517-***-****

ad4mhl@r.postjobfree.com

PROFESSIONAL SUMMARY

Skilled SAS Programmer/Analyst with extensive experience in pharmaceutical industry. Developed and enhanced programs and macros. Wrote and reviewed documentation including: data and programming plans and specifications; data presentation plans; peer-testing forms; statistical analysis plans; and end-user instructions. Proven ability to work independently and within team environments providing accurate and meaningful results. TECHNICAL PROFILE

Familiarity with: CDISC: STDM, ADaM data structures and concepts, Pinnacle 21. MedDRA / FDA and ICH guidelines including Good Clinical Practices and Good Programming Practices.

LANGUAGES/SOFTWARE: SAS, Windows-related MS products (Word, Excel, PowerPoint, Visual Basic), HTML, SQL, UNIX/LINUX. Python. FORTRAN

PROFESSIONAL EXPERIENCE

IQVIA August 2018 – April 2023

Statistical Programmer

• Worked on Phase I, II and III oncology and immunology clinical trials.

• Annotated Case Report Forms (CRFs) to SDTM standards.

• Created specifications for CDISC SDTM by using company standards.

• Annotated Case Report Forms (CRFs) to SDTM standards and worked on SDTM Spec creation and SDTM dataset generation followed by Pinnacle 21 activities.

• Generated production and QC SDTM and ADaM datasets per Spec and SAP.

• Generated Tables and Listings as per Mock shells and performed validation.

• Programmed and used in-house tools to create safety and efficacy tables, listings and figures for clients.

• Worked on Ad-hoc data transfers.

• Understand the programming scope of work, estimate the work completed and communicate the work status.

• Used and promoted the use of established standards, SOP and best practices.

• Familiar with and practices GPP practices including program header maintenance, uniform indentation of code and comments.

LARRY APUZZO PAGE 2 of 4

517-***-****

ad4mhl@r.postjobfree.com

Micro-Tech Computer Services Incorporated (Weatogue, CT) 2011 – 2016 Consulting firm working under Eliassen / eClinical Solutions

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Position: Senior Programmer (contractor)

Rheumatoid-arthritis

o Worked in team environments performing quality control by writing/modifying independent peer code for safety and efficacy analysis for various requests. These included demography, adverse events, descriptive statistics and normal approximations and ad-hoc tables, listings and graphs. o Programmed for production tables and data sets including writing programming plans and working with programming specifications.

Performed Peer Review / Peer Testing for programs/macros to create ADaM structured data sets according to provided specifications. Included use of CDISC Validator.

Worked on several Oncology studies independently and within team environment for Inotuzumab Ozogamicin: a humanized monoclonal antibody for the treatment of cancers including Non-Hodgkin Lymphoma, originally developed by Wyeth, Inc.:

o 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. o 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. This included performing QC checks on programs, output, and log files; fixing existing run-time errors; ensuring output was correct; and fixing program logic where needed. o Identified and categorized programs on UNIX directory to document the purpose of all existing programs as a means of cleaning up the directory and working toward consolidating programs within and across studies.

o 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.

o Performed QC and worked on ad-hoc requests for reports to EHA (European Hematology Association). This was delivered (loaded into SharePoint) a day ahead of schedule. o Performed QC and made some subsequent modifications to T&L for SRT (Safety Review Team) and BDR (Blinded Data Review) deliverables. QC work performed largely on efficacy tables and listings. These deliverables were loaded into SharePoint on schedule.

Received Pfizer Certificate of Achievement for contributing to exceeding 2011 quality and speed goals in support of Pfizer DevOps (Development Operations).

Completed Pfizer on-line trainings as assigned.

LARRY APUZZO PAGE 3 of 3

517-***-****

ad4mhl@r.postjobfree.com

BRISTOL-MYERS SQUIBB - Wallingford, CT 1997 - 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 IE 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. 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). LARRY APUZZO PAGE 4 OF 4

517-***-****

ad4mhl@r.postjobfree.com

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. - Ridgefield, CT 1993 - 1997

(International Pharmaceutical Developer and Manufacturer.) Clinical Data Programmer

Teamed with Biometrics and Data Management department and interfaced with Clinical Research, Statistics, and Marketing departments. Wrote, validated, and documented SAS programs and SAS macro code on IBM mainframe under VM/CMS and PC under OS/2 on client/server network.

Developed and modified SAS programs to assist Clinical Research department in preparing FDA submissions of Phase II and Phase III clinical studies by generating: data verification listings, edit checks (data screening), final tables and appendices, and special requests.

Worked in conjunction with Clinical Pharmacologist to categorize concomitant medications according to Drug Facts and Comparisons methodology to allow more stringent analysis of interactions of therapies.

Wrote programs to remap the structure of SAS data according to specifications regarding differences in multi- national data standards.

Modified and wrote programs to create statistical analysis data sets as specified by Statistics Department.

Attended SUGI 20 Conference in Orlando, FL 1995. PIRELLI ARMSTRONG TIRE CORPORATION - New Haven, CT 1988 - 1992

(Multi-State manufacturer and distributor of tires. North American subsidiary of Pirelli Inc.) Programmer/Analyst

Reported to Project Manager and interfaced directly with R&D, Manufacturing, Engineering and Quality Assurance departments within multi-platform MIS center that included Data General mainframes (MV-series), IBM (PC’s and RS6000), and DEC PDP 11/23. Developed, modified, and implemented various applications both independently and within team environments on projects including:

PC-Based Time and Attendance System: Prototype system using barcode reading time clocks and software.

Product Specification Consolidation: Consolidated programs of four separate product specification systems located at corporate R&D and three manufacturing plants.

R&D Testing: Interfaced PC and Data General Mainframe using LAN software to allow users ability to access product test results in a real-time environment. Interfaced TEKTRONIX plotter with DEC PDP 11/23 to graph product testing results.

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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