SUMMARY

• SAS Programmer with 8+ years of professional experience in Clinical Trial projects and SAS Programming in the CROs, Healthcare and Pharmaceutical industries.
• Experience in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM and Case Report Tabulation Data Definition Specification (Define.xml).
• Extensively involved in clinical data analysis and preparation of SAS Datasets, Reports, Tables, Listings, Summaries and Graphs according to the Standard Operating Procedures (SOPs).
• Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS.
• Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets.
• Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
• Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.
• Proficient in working with different clinical trials data like Demographic, Adverse Events (AE), Laboratory, Vital Signs etc.
• Involved in the process of generating TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Proven skills in data cleaning, ad - hoc reporting and coding using SAS on various environments.
• Good in performing CRF Annotation with respect to various database designs.
• Have excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success in multi-tasking, fast paced environment.

TECHNICAL SKILLS

SAS tools: SAS9., SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/QC

SAS Procedures: SORT, CONTENTS, TRANSPOSE, GPLOT, GCHART, FREQ, MEANS, SQL, REPORT, TABULATE, PRINT, SUMMARY, UNIVARIATE, CDISC, LIFETEST

Programming: SQL, RDBMS

Operating System: Windows 98/2000//2007/ XP

Database: MS Access, SQL Server 7.0,oracle 9i

PROFESSIONAL EXPERIENCE

Confidential, Buffalo, NY

SAS programmer

Responsibilities:

• Statistical research and analysis revolving around Clinical Outcomes and Healthcare cost-drivers.
• Generated and distributed standard reports weekly, monthly, and quarterly.
• Reported and analyzed cost of healthcare.
• Performed various data management activities like pre-processing of data, writing SQL queries, edit check programming, and statistical analysis using Base SAS and SQL.
• Derived data from other data bases and created SAS datasets for further analysis.
• Involved in analysis of Medication Adherence and Persistence across various chronic diseases among IHA’s population.
• Research on Generic Utilization and Brand Utilization trends.
• Analyze findings and prepare consolidated and ad-hoc reports to identify trends and issues.
• Prepare Pharmacy and Medical Trend analysis and savings reports.
• Work extensively with Medicare and Medicaid population and research on medication related re-admission rates.
• Generate PCIP profiles to compare physicians and other health care professionals performance. (cost review, disease prevalence etc)
• Generated reports using PROC FREQ, MEANS, TABULATE, REPORT, UNIVARIATE and TRANSPOSE.
• Used SAS/GRAPH to present data analysis-using PROC (GCHART, GPLOT etc.)
• Used SAS/STAT for descriptive statistical analysis - ANOVA, Frequency distributions and present results in Histograms and Box Plots.
• Participate in implementation of reporting systems to support the analytical needs of the company and its clients.
• Assisted seniors and fellow programmers in validation, edit checks and data review listings.
• Performed various Ad-Hoc analyses as per user guidelines and requests.
• Supported and attended requests from regulatory agencies, contracting agencies and other external organizations.

Environment: SAS SQL, SAS/Base, SAS/STAT, SAS/GRAPH, SAS ODS and MS Office.

Confidential, Columbus, OH

SAS programmer

Responsibilities:

• Mapping of Raw Data to SDTM data i.e. Generating SAS programs for creating SDTM domains like DM, EG, CM, AE, LB, EX etc.
• Reviewed Protocol, CRF, and SAP for creating Analysis datasets, Tables, Listings and Graph’s.
• Successfully validated TLG's through independent validation using PROC COMPARE.
• Analyzed data using various statistical procedures like PROC MEANS, PROC FREQ, PROC SUMMARY and PROC UNIVARIATE.
• Extensively used SAS procedures such as Print, Report, Freq, Means, Summary and Transpose for producing ad-hoc reports and in Data transformation and Manipulation processes.
• Created tabular and graphical reports and summary statistics using PROC REPORT, PROC PRINT, PROC GCHART and PROC GPLOT.
• Investigated missing data and data anomalies in SAS data sets.
• Able to meet the Deadlines and used modern techniques in programming to improvise and excel

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/SQL, Excel 2000, Oracle Clinical

Confidential, Jersycity, NJ

SAS Programmer

Responsibilities:

• Created, validated, documented, and maintained SAS programs to generate analysis datasets, and create safety/efficacy reports including summary tables, listings for use in regulatory submission.
• Developing and complying with project/study standards and specifications following internal guidelines.
• Generated Tables, Listing and Graphs according to the Reporting Analysis Plan (RAP).
• Generated Ad-Hoc reports for Data Review Meetings.
• Interacted with other line functions, such as Biostatistics,Data Management, to ensure a high level of client satisfaction through successful execution
• Generated Macros for tables and listing and used departmental Macros to produce reports
• Performed quality controls (QC) on SAS programs created by fellow programmers.
• Used Output Delivery System (ODS) to create a vast variety of reports both in RTF and PDF format.

Environment: SAS 9.1.3, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Excel/Access 2000

Confidential, Fort Worth, TX

Statistical Programmer (SAS)

Responsibilities:

• CDISC SDTM Experience - mapping of various phases of clinical trial data into the SDTM domains.
• Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort and Update, Formats, Functions and conditional statements.
• Programming and Validating tables, listings, analysis datasets and figures for inclusion in clinical study reports.
• Assisted, created, modified and developedsystemlevelmacrosandnew utility macros for standard reportingin accordance with theSDLCguidelines.
• Worked on Data Management, Familiar with user requests of CDC’s and CDM’s.
• Responsible for providing proper validation, including testing and documentation (e.g., requirements document, program validation), in accordance with GCP and company standards.
• Participate in the design and maintenance of a standard programming environment (i.e. file structure and development to production implementation strategy).
• Develop and maintain programs to meet internal and external client’s needs.
• Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphs, and listing summaries.

Environment: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, ORACLE, WIN NT

Confidential

Statistical Analyst

Responsibilities:

• Worked on diabetes control clinical trials.
• Imported datasets from different sources, e.g. spreadsheet of Excel, part of Excel spreadsheets, data files with delimiters, and so on.
• Organized datasets into forms for statistical analysis by merging, combining, splitting, and coding, and performed edit-check for datasets to assure the quality of the datasets.
• Developed new SAS programs and modified existing SAS programs.
• Independently created and performed change controls on macros to be used in developing analysis datasets.
• Supported lead programmer in electronic submission.
• SAS Macros were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Developed procedures to standardize analysis programs, including a macro library.
• Involved with the QC and Validation of SAS programs.

Environment: SAS v8. SAS/BASE, SAS/MACRO SAS/STATSAS/GRAPH, SAS/ODS, WINDOWS.

Confidential

Research Scientist

Responsibilities:

• Supervised method development and validation of new methods as well as scale up from pilot batches to manufacturing batches.
• Custom chemical synthesis and process research development.