Thomas Pineo Email & Phone Number

Performing prime and parallel programming for Phase III and IV studies for an Overactive Bladder drug (OAB).Work is performed in UNIX environment using SAS V8 or V9 using batch and interactive SAS as well as via Pfizer's reporting system, CDARS. All work is saved in Pfizer standard directory structure and is checked into RCS for file management purposes. Value add datasets (VADs) are generated via Pfizer system (CDARS). The process requires an extraction from OC and then running CDARS macros to create the standard VAD. In this study many of the VADs are non standard. In those instances it has been largely my responsibility to validate the VADs by writing parallel QC programs. By working to a detailed specification I generate derived endpoint variables and values per Pfizer Data Standards. I also write LOCF and windowing code per Pfizer standards. If I am writing QC code a compare is performed. Whether it is a QC or Primary program data checks are performed using procs Freq and Mean, and sometimes Univariate, as well as special edit checks and reports as needed. TLGs are generated via the CDARS system but about half of the TLG's end up being non standard in this study. By working to detailed non standard specifications I may write the primary programs or I may perform validation by writing parallel QC programs. Procs Means, Freq, Report and SAS/Graph procedures are commonly used. Proc Logistic in conjunction with OCS is often used for regression analysis reports. Compare tools can be used to compare large listings. This requires formatting the QC output exactly to specification. All primary and QC work is documented in detail in a common project tracking file (LoT - List of Tables). QC results and corrective action is documented in the LoT along with many other details. I work closely with statisticians and fellow programmers as needed but I am mostly self sufficient in writing code if the statistical requirements are clearly defined.

New York, New York, Us

Performed Phase I and II SCS programming in Pfizer's oncology studies.Worked with a team to import PC based programs created by PRA (CRO) into UNIX in preparation to begin further analysis of the data.The team completed the conversion of 24 oncology studies made up of a total of about 1200 programs, 938 macro programs, 1223 tables, 868 listings and over 800 figures.Mapped data and programming TLGs for a safety analysis of a cancer drug that has been used in dozens of studies to determine the risk of Myocardial Infarctions in subjects.

South San Francisco, California, Us

Worked as a QC programmer, working from home via internet.Performed independent, parallel programming of datasets, statistical tables, supporting listings and graphical presentations of clinical trials data.Used the client's QC tracking system to assign myself work requests placed on the tracking system by the primary programmers.Performed QC programming according to dataset, table and listing specifications, as well as SOPs and SAPs.Provided feedback in the form of questions, problems found and/or acceptance of the primary program.When the QC and Primary programs agreed and all problems were understood and repaired, the primary programmer and I finalized the QC request.Most of the work was for Phase III safety and efficacy clinical trials.

Was hired to support a CSS effort for a Crohn's Disease drug.Efforts have included developing safety summary tables, listings and Case Report Tabulations.The SAP called for the integration of 5 different studies into tables on demographics, subject accountability, drug exposure and safety (including AEs, laboratory parameters and vital signs).Generated summary tables and listings for demographics and baseline characteristics as well as safety tables, including vital signs, conmed use and lab data.

New York, New York, Us

Generated demographic, safety and efficacy statistical tables and corresponding listings in support of several flu vaccine studies.The efforts required frequent use of SAS PROC FREQ and PROC UNIVARIATE as well as SAS Macro language.Had to become very familiar with the protocols and SAPs.Programs were verified by means of dual programming.Worked closely with the statistician and peers on a daily basis.The studies were completed on time.

New York, New York, Us

Generated FDA required safety reports in their clinical reporting system CDARS. This effort required careful scrutiny of the quality of the data and the correctness of the resulting reports. Coordination with other programmers and data base managers was critical. Knowledge of basic SAS procedures and Macro language was essential. I validated the data and ensured the accuracy of reports for about 30 different studies in the short time I was there.

Raleigh, North Carolina, Us

Developed safety and efficacy analysis summary tables, listings, and derived data tables. Daily interaction with statisticians and peers as well as some interaction with clients developing statistical analysis plans, summary tables, and listings by interpreting protocols. Developing derived data tables through the use of CRFs and Protocols/SAPs.

Rochester, Ny, Us

Worked in Decision and WEB Support Services Department in support of Finance and Patient Accounts writing ad hoc and production reports using SAS on the IBM mainframe (TSO).Data was in SAS tables and large IMS files (7+ million recs).Output was directed to production delivery systems and/or FTP'd as tab delimited files on shared network drives to be imported into MS Excel.Extensive use of JCL, SAS Macros and DATA_NULL_ data steps as well as PROC FREQ, PROC TABULATE, PROC SUMMARY, PROC FORMAT and CNTLIN tables.

SAS Clinical Trials Programming in the Clinical Project Programming department.Developed many Phase I and II Final Oncology Drug Study Reports describing Dose Level Findings and Efficacy of certain cancer fighting drugs, including drug combinations and delivery methods.Interpreted CRFs (case report forms), CSRs (clinical study reports), Data Analysis Plans and Statistical Analysis Plans in order to structure the programs and generate the required output.Some types of statistics were Adverse Effects, Demographics, Death, Safety, Reason Off Study and Dosage.Provided SAS programming services in a Phase III (random comparative trials) neuroscience drug study for an NDA (new drug approval) effort.This was an ISS report (Integrated Summary of Safety) where data from many different studies of the study drug were combined to create composite data tables.Different studies had different data structures and much care was taken to put the data together where it could be or to leave separate.Converted and updated existing programs and created many new programs.All the programming efforts mainly required extensive use of SAS Macros, PROC TABULATE, PROC MEANS, PROC REPORT, PROC UNIVARIATE, PROC FORMAT libs as well as SAS Base skills in UNIX.

Supported code changes to SAS report applications that provided quality measurements for the annual HEDIS Reports mandated by the managed health care industry oversight committee NCQA.Job entailed updating/reengineering applications to meet new specifications.Upwards of 17 million records of claims data maintained in DB2 were batch processed by SAS in the IBM mainframe environment.Formal code walkthrough and testing was done.Changed management via Endeavor.

Us

Participated in the Computer Data Management and Analysis Department writing SAS report programs for management and marketing personnel.UNIX environment with large data files (10 gigs).Used SAS PROCs like PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC SUMMARY, SAS SQL (INFORMIX) and PROC PRINT.Used SAS Macros for dynamic code generation and code consolidation.Programmed KORN shell scripts to run SAS steps in parallel, checked their logs for errors and ran subsequent steps if logs were free of error.

Bad Homburg, Frankfurt, De

Member of team effort to migrate SAS data and applications from MVS to UNIX.Developed and changed code to migrate data and applications from MVS to UNIX.Wrote SAS programs to convert SAS Data Sets to transportable formats with PROC CPORT, transferred the files, reconverted to usable format using PROC CIMPORT and then reorganized the files into UNIX directories using shell scripts.Performed data integrity checks on all data tables using specially designed SAS programs to display the data to the various analysts of each responsible department.

Concord, New Hampshire, Us

Member of team effort to develop a SAS-powered, client-server based Data Warehouse.Duties included acquiring data from various systems which involved among other duties, converting copy books to SAS input statements and ensured the data was validated by the users and met the Data Warehouse standards created by the development team.The warehouse consisted of hundreds of SAS data tables and millions of rows of data.

Developed a LAN-based cost tracking system using Personal AS and menus to provide easy access to scrap and rework cost data for non programmers.Developed and supported a quality reporting/data entry system in MVS that used ISPF tables, skeleton files and SAS code with imbedded DB2 queries and CLIST to process user selections and dynamically generate SAS reports.The users could specify variables and values to select data by, as well as specify output types such as frequency reports, summaries, listings and others.The system required daily, weekly, monthly and yearly data archiving, maintenance and access control, as well as periodic maintenance of the many applications.Developed a manufacturing self inspection data entry and reporting system that was put in place to replace the need for 100% inspection and manufactured products.This system was developed in MVS using AS data tables and procedures and imbedded DB2 queries that were driven by ISPF menus and CLIST.Developed a MVS based trend analysis system that was put in place to preclude the need for component testing, saving millions of dollars.This system dynamically generated AS code with imbedded queries and flagged components that exceeded specified failure thresholds during any time through the manufacturing and test cycle.This application was ambitious and was highly successful and cost effective.Worked in LAN hardware and software support for a large network consisting of IBM Token Ring and many LAN based E-mail, word processing and database products.Supported and improved a VM based supplier performance measurement system.Archived old data and maintained access authority to the SQL data tables and other data files.