SUMMARY:

• SAS Programmer/ Analyst with over ten years of work experience in the pharmaceutical industry using SAS programming skills for data extraction, manipulation, management, analysis and reporting.
• Extensive experience in clinical data analysis, producing reports, listings, tables, summaries and graphs from clinical trial data of all the four phases of clinical trials.
• In - depth knowledge in SAS system - BASE, STAT, MACRO, SQL, GRAPH.
• Experience in reading raw data from Oracle Clinical into SAS data sets and then converting them to SAS analysis data sets.
• Extensive experience in preparation of ad-hoc reports, tables, listings and graphs based on the Protocol, SAP or SOPs and Mock-Up Shells., documentation and program specifications.
• Extensive experience in programming to create derived datasets for safety and efficacy analysis
• Advanced knowledge and usage in procedures like PROC SQL, REPORT, TABULATE, GCHART, GPLOT etc.
• Good knowledge in statistical procedures like PROC MEANS, FREQ, UNIVARIATE, ANOVA, GLM etc.
• Strong in ODS for delivering the outputs in different formats like HTML, RTF, PDF and custom reports.
• Good knowledge on using custom MACROS and writing MACROS.
• Good knowledge on edit checks, data cleansing of disorganized and complicated data and validation.
• Knowledge of phases I IV of clinical trials including NDA, IND and FDA submission procedures. Experience in writing SAP requirements and designing protocol.
• Extensive experience in documentation of pre-written macros and programs, writing program and derived datasets specifications using Companies and industry standards
• Knowledge of Document Management Systems Validation of GMP regulated environments, FDA Quality System Regulation, FDA Compliance, FDA s 21 CFR part 11, GCP guidelines and CDISC Standards.
• Solid knowledge in scientific base of clinical research in Oncology and other therapeutic areas helping to analyze laboratory, biomarkers and other study specific data
• Excellent analytical, problem solving, enthusiastic, innovative, challenge oriented and a team player

TECHNICAL SKILLS:

Computer environments: MS DOS, UNIX, Windows XP SAS system (BASE, STAT, MACRO, SQL, GRAPH), IREVIEW

Spreadsheet and presentation software: MS EXCEL and POWER POINT

PROFESSIONAL EXPERIENCE:

Confidential,Silver Spring, MD

SAS Programmer

Responsibilities:

• Develop and maintain SAS programs for SDTM to ADaM Traceability Analyses
• Perform and present Integration Safety Summary (ISS) Assessment Analyses for CDER scientific reviewers

Confidential, Marlborough, MA

Senior Statistical Programmer Consultant

Responsibilities:

• Programming and validation of safety and efficacy SAS datasets
• Generate tables, listings, figures for current and Final Study Reports of multiple protocols for Medical Device studies

Confidential, Somerset, NJ

Senior Statistical Programmer (Home based)

Responsibilities:

• Plan and establish approaches for coding validation programs and implement best practices for program s documentation for Data Management and Biostatistics Department.
• Convert raw and legacy data to SDTM datasets, validate SDTM datasets.
• Develop programs for data transfers, dataset generations, validation and statistical analysis programming requests effectively for Department members.

Confidential, Woodcliff Lake, NJ

SAS Programmer Analyst Consultant

Responsibilities:

• Work with clinical study teams in the development and activities related to statistical analysis for ongoing clinical studies.
• Plan and establish approaches for coding programs and implement best practices for program s documentation for Data Analysis, Clinical Informatics, Scientific Operations and Clinical Support Biostatistics group.
• Develop programs for data transfers, dataset generation and statistical analysis to deliver clinical and statistical related programming requests effectively for Department members. Interact with Statisticians to generate ad - hoc reports using various statistical procedures: PROC LIFETEST, PROC PHREG, PROC MIXED etc.

Confidential, Cambridge, MA

Senior SAS Programmer Consultant

Responsibilities:

• Responsible for Confidential t Profile programming, outputs generation for Oncology clinical trials
• Produce and validate Confidential t Profiles multiple listings, tables, figures using SAS for clinical study reports, conferences, internal data reviews, and ad hoc analyses. Use SAS ODS facility to write custom reports directing SAS output to RTF, PDF destination files.
• Generate edit checks outputs for data analysis
• Generate multiple types of listings, tables, derived datasets supporting Data Management - MedDRA, WHOdrug coding etc., create output excel files.

Confidential, Northborough, MA

Senior Statistical Programmer Consultant

Responsibilities:

• Programming and validation of safety and efficacy (BAYESIAN analysis) SAS datasets
• Programming Randomization Schedule
• Generate tables and listings for current and Final Study Reports of multiple protocols for Medical Device studies
• Write, modify and program edit checks for Database analysis

Confidential, Princeton Jct., NJ

Senior SAS programmer Consultant

Responsibilities:

• Generate tables and listings for Integrated Safety Analysis (ISS), Final Study Reports
• Design, code, test, and validate study - specific programs and drivers, modify and validate standard programs for multiple protocols
• Develop and maintain programs, tests, validation related to structuring programs and derived output datasets

Confidential, Florham Park, NJ

Senior Clinical SAS Confidential t Profile Programmer/eCRF Developer

Responsibilities:

• Responsible for Confidential t Profile programming, outputs generation, IREVIEW program registration of multiple protocols for Oncology studies.
• Write, modify and edit check the SAS core programs, driver s programs and macros in macro library.
• Produce and validate Confidential t Profiles multiple listings using SAS for clinical study reports, conferences, internal data reviews, and ad hoc analyses.
• Write detailed Confidential t Profiles programming specifications, prepare for clinician s approval
• Protocol Deviations programming and validation for new eCRFs trials, produce Protocol Deviation reports
• Use SAS Output Delivery System (ODS) facility to write custom safety reports using pre - existing templates directing SAS output to RTF, PDF destination files.
• Support development of Oncology Standard eCRFs, Oncology Data standardization

Confidential

Lead Efficacy SAS Programmer Consultant

Responsibilities:

• Responsible for the input into specifications for analysis (including derived datasets, listings, tables, graphs) of clinical trials across Phase II - IV and for project deliverables
• Produced and validated safety tables and listings using SAS for NDA submission, clinical study reports, conferences, internal data reviews, and ad hoc analyses.
• Create efficacy derived datasets and validate efficacy programs using SAS for statistical analysis.
• Generation of high quality tables, listings and graphs of clinical trials and project deliverables from analysis plan, including ad-hoc exploratory analyses

Confidential, New York, NY

SAS Programmer /Analyst

Responsibilities:

• Planning, implementation and coordination of SAS programming supporting eCRF development, biostatistics and clinical trials from study start - up to database finalization for multiple protocols - Oncology and General Medicine therapeutic areas.
• Create SAS datasets according CDISC (Clinical Data Interchange Standards Consortium) standards

Confidential, Wallingford, CT

Clinical Project Programmer/Analyst

Responsibilities:

• Assumed full protocol reporting responsibility: extract data, generate data review tables and listingsupdate the intranet safety reporting site.
• Generated tables and listings for Integrated Safety Analysis (ISS), Final Study Reports, Executive Summary and Appendices in NDAs for FDA submissions, closely worked with Medical Writers in assisting for Clinical Study
• Report (CSR) and publications preparation.
• Designed, coded, tested, and validated study - specific programs and drivers, modified and validated standard programs for multiple protocols Developed and modified drug exposure (dosing), eligibility criteria violations and protocol deviation programs for multiple protocols (Phase I - III).
• Developed and maintained programs, tests, validation related to structuring programs and derived output datasets.

Confidential

SAS Programmer Consultant

Responsibilities:

• Statistical tables and listings generation using Management, Analysis and Reporting f Safety Data (MARS) SAS application for clinical trials analysis (Phase I - III), cardiovascular drugs therapeutic area

Confidential, New York, NY

SAS Programmer /Analyst

Responsibilities:

• Statistical analysis using SAS procedures (PROC MEANS, FREQ (including P - value)UNIVARIATE, ANOVA, GLM etc.) for PK studies
• Creation listings and tables for clinical trials analysis using PROC REPORT

Confidential, Hawthorne, NJ

SAS Programmer

Responsibilities:

• Developed SAS programs for data handling, including conversion from ORACLE database to SAS data sets using SQL
• Quality checks to perform detailed analysis of the data (range check, cross table logical checking etc.)
• Program validation. Results auditing based on randomization
• Export and Import SAS data sets
• Produced listings and tables

Confidential, New York, NY

Research Analyst

Responsibilities:

• Participated in table shells design for artificial skin clinical trials (phase I - III)
• Performed statistical analysis of experimental and clinical data using SAS/STATSAS/GRAPH
• Prepared documentation materials for FDA

Confidential, New York

Clinical Laboratory Analyst

Responsibilities:

• Involved in clinical studies of tuberculostatics and drugs used in AIDS treatment, performed statistical analysis using applications of correlation analysis.

Confidential, New York, NY

Research Associate

Responsibilities:

• Investigated genetic regulation of epithelial cell differentiation
• Performed statistical analysis of experimental data, used MS Power Point, MS Excel

Confidential

Research Associate

Responsibilities:

• Involved in Russian/American Program of new hypolipidemic drugs studies and clinical trialsperformed clinical data statistical population analysis
• Participated in new cytostatic drugs clinical pharmacological evaluation, used clinical and experimental data statistical methods of analysis