SUMMARY

• SAS Programmer with over 7 yrs of experience in clinical research domain emphasizing on analysis, developing, design, mapping, testing and implementation of various projects for Pharmaceutical, Biotechnology and Healthcare Industries.
• Currently associated with Readinghealth org., working with clinical trial data on congestive heart failure.
• Worked on various areas of therapeutics including cardiovascular, obesity, diabetes and central nervous system.
• Experience in implementing CDISC standards to clinical trial data through converting raw data sets to SDTM and ADaM datasets with reference of mapping documents prepared by following SDTMIG.
• Performed Statistical Analysis (Regression and ANOVA), predictive modeling, and mixed models using SAS/Stat.
• Good experience of documentation of clinical trial data based on GCP/ICH guidelines, 21 CFR part 11 and FDA regulations related to data management.
• Expertise in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ACCESS, SAS/ODS, SAS/REPORTS.
• Followed System Development Life Cycle (SDLC) methodology for the design, development, implementation, and testing of various SAS modules.
• Strong experience in Statistical Analysis, Reporting and Clinical Data Management.
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macros to improve ease and speed of modifications as well as consistency of results.
• Good knowledge of Clinical Trial Management System (CTMS), GCP, Clinical trial phase I - phase IV.
• Experience in SAS/STAT procedures like PROC UNIVARIATE, CORR, REG, ANOVA and TRANSPOSE.
• Experience in Query Optimization, Debugging, and Tuning and Improvising performance of the applications.
• Excellent organizational, teamwork, presentation, interpersonal and Communication skills.
• Possess critical thinking, problem solving, and decision making skills to dismantle complex problems and optimize solutions.

TECHNICAL SKILLS

SAS tools: SAS/BASE, SAS/GRAPH, SAS/ODS, SAS/MACROSSAS/STAT, SAS/SQL, SAS/ACCESSSAS/CONNECT, SAS/REPORTS, SAS/AF, SAS/EIS,SAS/BI

SAS Procedures: Print, Freq, Sort, Means, Univariate, Report, Correlation, SQLTranspose, Import, Export, Summary, Format.

Database: SQL e SQL server,MS Access, velos, oasis, oracle, teradata

Operating Systems: Windows XP, MS DOS, UNIX

Other Access: MS Office tools like MS Access, MS word, MS PowerPointMS Excel.

PROFESSIONAL EXPERIENCE

Confidential, West Reading, PA

Clinical SAS Programmer

Responsibilities:

• Provided SAS programming solutions in the production of Patient level Datasets, Tables, graphs, Listings and Cross-study Summaries from Clinical Trial data. Created SAS MACROS for repetitive tasks and extensively used existing MACROS to develop SAS programs for Clinical Data.
• Performed the role of modeler by generating predictive analysis reports such as survival analysis, logistic regression and multiple regression models.
• Transformed raw datasets in to SDTM datasets as per CDISC SDTM 3.1.2 version.
• Created Analysis datasets (ADaM) from SDTM datasets as per the analysis specification Documents.
• Created tables, figures and listings as per the client specification using PROC REPORT, proc means, proc freq, PROC FORMAT, PROC GPLOT, SAS/ODS and DATA NULL for data presentations.
• Generated data in define.xml format for FDA submissions.
• Collaborated with other SAS programmers in Data Validation, Code Validation and Results Validation.
• Involved with team of biostatisticians to conduct QC analysis of Tables, Graphs, Listings (TGL’s) and Outputs.
• Involved in designing of eCRFs and edit checks.
• Developed SAS MACRO codes for data manipulation, data analysis, statistical analysis and routine report generation.
• Performed Efficacy Analysis and Safety Analysis using SAS/STAT procedures as specified in SAP/Protocol and prepared Tables, Listings and Figures (TLF’s) for Clinical Study Report (CSR).

Environment: Windows, MS Access, SQL Server, SAS/BASE, SAS/STAT, SAS/MACROS

Confidential, Collegeville, PA.

Senior SAS Programmer

Responsibilities:

• Worked extensively to generate SAS data sets, statistical reports, monthly reports, listings, safety reports for cross-functional teams for Phase I to II of Clinical Trial Drugs Data.
• Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs. Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Worked on CDSIC SDTM 3.1.2 version datasets generation from raw data as well as Analysis datasets.
• Provided data management deliverables such eCRF specifications, Data Validation Specifications (DVS) and review the data management plan.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Created SAS Customized Reports using the Data Null technique. SAS/STAT procedures such as UNIVARIATE, FREQ and MEANS were used to carry out analyses and the SAS REPORT procedure is generally used to display results.
• Extracted data from Oracle database transformed and loaded into Teradata database according to the specifications.
• Used SAS ODS to produce HTML, PDF and RTF format files.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Figures.
• Data validation was done using SAS Enterprise guide.

Environment: SAS v.9, SAS/BASE, SAS/SQL, SAS/Macro, SAS/STAT, SAS/Graph, SAS/Report, SAS/ODS.

Confidential, Minneapolis, MN

Clinical SAS Programmer

Responsibilities:

• Worked in Phases of clinical trials for heart diseases and diabetes.
• Designed and implemented statistical reporting processes for clinical data analysis.
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time and created tables, listing and graphical reports.
• Worked with different Sources such as Oracle, SQL Server and Flat files.
• Generated output files in text format, HTML & PDF format using SAS ODS.
• Created SAS transport (.xpt) files and converted the Transport files into SAS Data Sets.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Designed flow charts indicating the input datasets and the techniques that would be used (sort, merge, append) to get the desired output.
• Data Analysis and graphical presentation for various summary reports using Base SAS and SAS/Graph facility.
• Developed SAS programs for listing of tables for data review and presentation including adhoc reports, CRTs (Case Report Tabulations) as per CDISC, patients listing mapping of safety database and safety tables.
• Developed ADaM datasets as per client requirements based on CDISC standards.
• Created CRT datasets using CDISC standards for submissions to the FDA.
• Performed data validation on the data sets and deleted repeated values using conditional data steps such as @@, if-then statements.
• Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials.
• Established and maintained a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Database personnel.

Environment: SAS/BASE, SAS/SQL, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ODS, ORACLE, Windows, Excel, SQL, SPSS.

Confidential, Marlborough, MA

Clinical SAS Programmer

Responsibilities:

• Developed SAS programs for creating intermediate data sets, generating statistical reports and graphs as per statistical analysis plan.
• Importing the data in to SAS from Excel Spreadsheet using PROC IMPORT.
• Generated tables and listings based on CDISC (SDTM V3.1.2) standard.
• Created Integrated Summaries of Efficacy (ISE) and Safety (ISS) as per FDA compliance.
• Extracting data from the database using SAS/Access, SAS/SQL and PL/SQL procedures to create SAS data sets.
• Involved in data validation and creation of several macro programs which were modified and used for validation across different studies and protocols.
• Involved in Statistical Analysis using PROC REG, PROC GLM and PROC ANOVA.
• SAS programs and macros were developed for clinical trial data analysis and generated Tables, listings and graphs.
• Used procedures like PROC TRANSPOSE, SORT, etc in Data transformation and Manipulation processes.
• Modified/created various macro definitions for preparation of analysis plans.
• Conducted SAS multivariable statistical analysis of the trial.
• Merged Demographics (DM) and efficacy datasets to generate various reports.
• Used Dynamic libname, proc sql, proc sort, proc export, proc compare, Proc import, proc append, proc report and proc format.
• Performed basic SAS analysis on existing customer’s data, and database segmentation using PROC MEANS, FREQ, SUMMARY AND TABULATE.
• Conducted validation of SAS programs and summary reports.

Environment: SAS (BASE SAS, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/SPSS), MS Access.

Confidential, Irvine, CA

Associate SAS Programmer

Responsibilities:

• Worked in Phase II & III of clinical trials for studies in the eye care and neuroscience therapeutic area.
• Converted the clinical trial data, subject records entered in the database files to SAS data sets using SAS/Access.
• Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS tools - SAS/GRAPHS, SAS/STAT and Base SAS.
• Dealt with different raw data sets including CONS, LABS, VITALS, ENROL, ECG and used DATA STEP to create analysis datasets by merging, combining, splitting, and coding.
• Used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS.
• Used procedures Proc Means, Univariate, Freq and Compare to identify outliers.
• Converted existing raw data into CDISC standards and reviewed CRFs to ensure consistency and adequacy in data in order to meet the objectives defined in protocol.
• Used procedures like PROC TRANSPOSE, SORT, etc in Data transformation and Manipulation processes.
• Produced customized reports by using PROC REPORT and also provided several descriptive statistics using statistical procedures.
• Implemented CDISC SDTM Standards for submissions.
• Produced customized listings and summary reports using various procedures and formatted HTML, RTF or PDF reports using SAS/ODS (output delivery system).
• Carried out all activities according to SOPs. Ensured adherence to programming guidelines.
• Generated tables, reports, listings and graphs for Clinical Study Reports in compliance with 21 Code of Federal Regulations (21 CFR) Part 11, FDA and GCP guidelines.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.

Environment: SAS 8.2/Base SAS, SAS/ACCESS, SAS/STAT, SAS/GRAPH, SAS/MACROS, SAS/REPORT, MS EXCEL.

Confidential

Jr. SAS programmer

Responsibilities:

• Worked on Phase I and II Clinical Trials.
• Used SAS Base procedures like PROC FREQ and PROC UNIVARIATE to generate Safety tables (Adverse Events, Demographic listing) and quality tables for clinical study reports and regulatory submissions.
• Developed SAS macros for data cleaning and Reporting.
• Generated statistical analysis files, tables, listings, and graphs for clinical trial studies
• Involved in delivering output using SAS/ODS.
• Extracted data from databases and also flat files.
• Created html and PDF output files by using SAS ODS AND PROC REPORT, PROC TABULATE, DATA NULL AND PROC SQL to customize the reports
• Enhanced reports through the use of labels, SAS formats, user-defined formats, titles, footnotes and SAS system reporting options.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSM, TRUNCOVER, MISSOVER etc.

Environment: SAS/ODS, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, MS EXCEL, MS ACCESS.