SUMMARY

• SAS Professional for 20+ years with Pharmaceuticals and CROs. Biometrics, Biostatistics, Statistical Programming, Database Management, Information Technology experience.
• Background includes Pharmaceutical SAS Programmer, Sr. Statistical Programmer, Statistical Analyst, IT Engineer,Validation/QA Review,Software Testing, Scientific Programming.
• Project Lead Programmer providing the programming support to the projects, negotiates the timelines, communicates across different functions and resolves the issues for the projects.
• Thorough understanding of Clinical Database, CDM methodologies, CRF, Statistical Analysis Plan, Clinical Trial operations, Drug Development process.
• Proficient in Analysis Datasets, Data manipulation, Listing reports, Graph generations for the Statistical Analysis Plan. Safety, Efficacy reports. ISS, NDA, DMC experience.
• CDISC standards, compliance for SDTM,ADAM datasets using openCDISC validation, Pinnacle21.
• Senior SAS Professional demonstrating expertise in SAS/Base, STAT, Graph, SQL, Macro, ODS, Report, Compare. Survival Analysis, Hazard Analysis and figure generation.
• Validation/QC/Review of Datasets/SAP programs and Software Libraries, UAT, Test Scripts.
• Follow all company Standard Operating Procedures and GCP Standards of Pharmaceuticals, CROs, Laboratories, Hospitals. Knowledge of FDA regulations.
• Analytics/Computational Engineering with neural networks/machine learning, publications.

TECHNICAL SKILLS

• SAS (v6.12, v8.2,v9.2,9.3,9.4,SasStudio,EG), Biostatistics/SAS, Biomedical Analysis, SPSS, BMDP, Splus, R, Jmp, Fortran, C/C++, Matlab
• SQL/Oracle, Oracle Clinical, RS1/Clintrial, Rave, Inform, Datatrak
• Biomedical Computing, Neural Networks, Bioinformatics, Labview
• Windows, Unix, VAX, PDP, Macintosh

PROFESSIONAL EXPERIENCE

SAS Statistical Programmer

Confidential, King of Prussia, PA

Responsibilities:

• Staff programmer/Validation for Clinical Analytics /Real World Data applications.
• Validation/QC programming for ISS/ISE Statistical Analysis Plan/TLF for pharma project.
• SAS v9.4, SAS Studio, SAS Enterprise. Remote/home - based.

SAS Stat Programmer

Confidential, Bound Brook, NJ

Responsibilities:

• Edit specification programming and validation for Data Management /Oncology project.
• Report programming, qc/review for Statistical Programing/CardiovascularMedDevice project.

Sr SAS Programmer

Confidential, Overland Park, KS

Responsibilities:

• Validation and program revision of SDTM, ADAM datasets required for SAP, PK datasets.
• CDISC compliance of SDTM, ADAM Datasets by validating with OpenCDISC (Pinnacle21);
• Reviewed Pinnacle21 reports. Implemented revisions to SDTM,ADAM datasets.

SAS Programmer Analyst II

Confidential, Bala Cynwyd, PA

Responsibilities:

• Staff programmer/Validation assigned to Pharmaceutical Drug Development protocols and Data Monitoring Committee (DMC) projects, Phase 2-3 Cardiovascular projects.
• Provided Programming and Quality Assurance/Validation of analysis datasets, standard and custom data listings, summary tables, graphs as specified in the Statistical Analysis Plan.
• SAS Base, Stat, Macro, Gplot, Report. Survival,Hazard analysis - lifetest,phreg,compare.

SAS Sr. Statistical Programmer

Confidential, Billerica, MA

Responsibilities:

• Work remotely with worldwide team for pharmaceutical clinical trials following SOPs, GCP and major Pharmaceutical client standards and policies (FSP projects).. Phase 2, 3, and 4.
• Program development and validation for SAS Analysis datasets, Table, Listing, Figure for the Statistical Analysis Plan. Software Validation and QC. Data Review.
• SAS macros for efficient programming. Reviewed,revised Analysis Dataset spec documents.
• Validation of SDTM, ADAM datasets to ensure CDISC compliance. Data transfers/Inform.

SAS Clinical Programmer

Confidential, Blue Bell PA

Responsibilities:

• Provided program development.validation of SAS TLF following the Statistical Analysis Plan of pharmaceutical clinical trial projects..Patient Profile Reports. Phases: 2-3-4.

SAS Programmer

Confidential, King of Prussia, PA

Responsibilities:

• Phase 1. Provided Program development and Validation for the Safety Statistical Analysis Plan and PK/PD Statistical Analysis Plan. PK datasets. Database Review Program.
• SAS Base,Stat,Macro,Gplot,Report,Compare. Assist define.xml validation,openCDISC tools.

Sr. SAS Statistical Programmer

Confidential, Wilmington, DE

Responsibilities:

• Database construction,derivation mapping requirements. CDISC SDTM,ADAM datasets.
• Developed and validated Analysis Datasets, TLF for Statistical Analysis Plans for protocols.
• Validated and QC final project reports. Utilized vendor report application.

Sr. SAS Programmer

Confidential, Princeton, NJ

Responsibilities:

• Program development and validation of Adam datasets,TLF following SAP.
• Utilized Excel. SAS Base, Stat, Macro, SQL, Gplot, proc Compare. Datatrak for datasets.
• Ensure CDISC compliance of SDTM submission datasets by openCDISC, proc cdisc.
• Participate with Data Management for specialized programming projects.
• Utilized SAS XML Mapper for specialized data mining project for Marketing department.

Sr. SAS Statistical Programmer

Confidential, Chadds Ford, PA

Responsibilities:

• Programming and Validation of the protocol SAP Tables, Listings and Figure reports.
• Followed CDISC standards, for validation of Adam, SDTM datasets.

Confidential, Hopewell, NJ

Responsibilities:

• Pharmaceutical Global Biometrics Department.
• Validation of Pharmaceutical Software Library and System Testing of in-house real-time Biometrics system.UAT. Test Script Documentation.
• Validation of Oracle Clinical-SAS dataset transfers. SAS, Splus, ClinPlus, Oracle Clinical.

Confidential, Bound Brook, NJ

Responsibilities:

• SAS with Confidential ClinPlus application.
• Programming,validation of analysis datasets,TLF reports, for clinical drug trials SAP.
• Validation of Efficacy, Safety, ad-hoc analysis reports. ISS support. openCDISC validation.
• Oncology project validation,survival analysis, lifetest, phreg, logistic, survival graphs.

Confidential, Bridgewater, NJ

Responsibilities:

• SAS Programmer in Data Management department, Oncology division, programming Patient Profile Reports and Data Review Report (DRR) Applications. Oracle Clinical.

Sr. SAS/Biostatistical Programmer

Confidential , Basking Ridge, NJ

Responsibilities:

• Project Lead Programmer in Biostatistics and Biometrics teams for clinical trials projects.
• Programming and Validation of the Analysis Datasets, Tables, Listings, and Figure reports for pharmaceutical SAP protocols. Oncology projects.
• Creation and validation of Efficacy, Safety, Ad-hoc Analysis, Survival Analysis SAS reports.

SAS Statistical Analyst/Biostatistics

Confidential, Morristown, NJ

Responsibilities:

• SAS, S-Plus, Fortran programming and analysis in PK division/Biostatistics department.
• Production of PK dataset, lab excel tables for NONMEM population analysis.PK programs.

SAS Sr. Statistical Programmer

Confidential, Eatontown, NJ

Responsibilities:

• Programmed and Validated Analysis Datasets, Tables, Listings, Graphs for SAP projects.
• Validated Safety, Efficacy reports and Efficacy Datasets.

SAS Clinical Programmer/Information Technology Engineer

Confidential, Radnor, PA

Responsibilities:

• Programmed TLF for the Statistical Analysis Plan, and for Safety and Efficacy reports.
• Maintenance of Documentum project management for lead programming projects assigned.
• Provided reviews for SAP, TFL shells and Protocol Documents.
• Assisted with Validation of TLF Reports and Statistical Macro Library.
• Assisted with regulatory support for ISS data integration project and pre-NDA project.
• Utilized SAS, Oracle Clinical. Projects include Oncology, Cardiovascular, Women’s Health.

SAS Programmer/Analyst and Clinical Database Manager

Confidential, Blue Bell, PA

Responsibilities:

• Report Programming performed for Data Management department for clinical trial projects.
• Clinical Database Manager for Data Management (6 months). SAS, RS/1, Clintrial.

RS/1 and SAS Biomedical Programmer

Confidential, Rockville, MD

Responsibilities:

• Programming RS/1, SAS for Clinical Laboratory analysis reports for Laboratory projects.

C Programmer

Confidential, Bala Cynwyd, PA

Responsibilities:

• C Programmer/Analyst for satellite engineering department developed for Mac and PC/Win.
• Created Analysis application tools and report development for satellite engineer projects.

Scientific Programmer/Analyst

Confidential, Philadelphia, PA

Responsibilities:

• Epidemiology, Population Division. Created Epidemiology Reports. Oracle/SQL,Fortran.

Research Assistant/Biomedical Engineering, Programmer/Analyst

Confidential, Philadelphia PA

Responsibilities:

• Neural network research for biomedical engineering, rehabilitation engineering applications and devices. Fortran. C, SAS, BMDP. Unix, DEC PDP, Macintosh.

Research Assistant/Clinical Technical Staff, Scientific Programmer/Computer Manager

Confidential, Philadelphia, PA

Responsibilities:

• Gait&Motion Analysis Lab. REC-2,RT-8 Rehabilitation Engineering & Research Centers.