SUMMARY

• More than 8 years of Clinical SAS Programming experience with extensive Data Management.
• Excellent work experience in generating tables, figures, and listings (TFL) for integrated summaries of ISS (Integrated summaries of safety) and ISE (Integrated summary of efficacy).
• Strong working knowledge on all 4 phases (Phase I, II, III, IV) of clinical trials and their designs including open - labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.
• Involved in Three Phases (I-III) of the Clinical Trials in different Therapeutics areas - Cardio-Vascular, Oncology, Respiratory trials and Cancer therapies.
• Mapping of data according to CDISC standards and created SDTM and ADaM datasets as per CDISC standards
• Extensively worked on IMS and SYMPHONY PHAST extracts to produce weekly and monthly topline reports for the eye care, Dermatology care to the marketing team.
• Worked on creating SAS datasets for several drugs to create the monthly sales report and there percentage of growth and decline in the sales with their market competitors.
• Extensive experience in using various SAS tools such as SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH, and SAS/ODS, SAS/ACCESS.
• Experience in Data Manipulation procedures such as SAS Formats / Informats, Merge, PROC Append, PROC Sort and PROC Transpose.
• Experience in implementing CDISC SDTM for interventions, events and finding domain models and ADAM standards, Define .xml and CRTs.
• Familiar with CRF, SAP, Protocol, FDA regulations.
• QC analysis and validation using PROC Compare and developing parallel programs.
• Strong skills in Clinitrial,Teradata, Oracle Clinical, SAS, SQL, PowerPoint, MS Excel, MS Word, and MS Access.
• Experience in providing statistical support for clinical studies.
• Experience in producing external files and reports employing various SAS statements and procedures, such as null, ODS, PROC Print, PROC Report, PROC Tabulate in Clinical Trials.
• Experienced in producing RTF, PDF, HTML and MS Excel formatted files using SAS ODS facility.
• Worked extensively on various SDTM domains such as AE, CM, LB, DM, SE, EG, EX, IE and their SUPPQUAL datasets.
• Developed programs in SAS Base for converting the Oracle Data for a phase I - III study into SAS datasets using SQL Pass through facility.
• Have extensive knowledge on R programming, implementing statistical and graphical techniques including linear and nonlinear modeling, time series analysis
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Connect, SAS/Enterprise Guide and has good knowledge of GCP, GPP and US FDA & 21 CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well.
• Have thorough knowledge on MedDRA (SOC, HLGT, HLT, PT, LLT) used for regulatory submissions.
• Knowledge of Pharmacokinetic and Pharmacodynamics properties of the drug.
• Independent working ability and Good team player with excellent organizational and documentation skills with excellent communication and presentation skills.

TECHNICAL SKILLS

Statistical Software: SAS/ACCESS, SAS/BASE, SAS/GRAPH, SAS/MACRO, SAS/ODS, SAS/SQL, and SAS/STAT.

Programming Languages: SAS, SQL, PL/SQL, HTML, C, and C++.

Data base: MS Access, Oracle Clinical.

Operating Systems: MS DOS, Windows 95/98/NT/2000/XP, Windows Vista, UNIX.

PROFESSIONAL EXPERIENCE

Confidential, Bridgewater, NJ

Senior SAS Programmer

Responsibilities:

• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros.
• Provide SAS programming expertise in the production of the derived datasets, tabulations, and cross-study summaries from prescription marketing data.
• Created weekly and monthly topline reports for several drugs and explain the sales growth comparing with the competitors in the market.
• Extensively worked on DDE using SAS to make the excel file open, close, write and save to the correct path in a specified location.
• Made several power points for individual drugs from the excel reports by linking up.
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for data cleaning and Report generation.
• Created datasets in SAS by Using PHAST 2.0 data from SYMPHONY and extracted the reports to excel by using PROC EXPORT.
• Perform several data management programs.
• Perform data pre-processing and dataset preparation for particular statistical analysis, including checking data quality, handling missing value and duplicate key, clean-up duplicate records.
• Provide district ranking and territory ranking to the marketed products by using Proc RANK
• Produced reports by using DDE and provided descriptive statistics using PROC MEANS, PROC FREQ, PROC UNIVARIATE, and PROC TABULATE.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/TOOLS, SAS/BASE, SAS/MACRO and SAS/SQL, SAS/ACCESS.
• Developed SAS macros for data cleaning and Reporting and to support routing processing using SAS to analyze data, statistical tables.
• Participated in study locks by doing the final analysis of the data and reports.
• Pulled out data from the clinical database and prepare customized analysis datasets for specific reporting needs.
• Performed analysis of datasets by using SAS procedures such as Proc Means, Proc SUMMARY, and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.

Environment: SAS 9.2, SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, Windows XP, and MS Access

Confidential, Houston, TX

Senior Clinical SAS Programmer

Responsibilities:

• Provide SAS programming expertise in the production of datasets, tabulations, graphics, listings, and cross-study summaries from clinical trial data.
• Creating SDTM datasets according to FDA submission guidelines for several studies in oncology therapeutic areas.
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
• Retrieve clinical and lab data from Oracle database and generate SAS datasets.
• Mapping integrating study data to a CDISC-compliant proprietary analysis data system(SDTM)
• Review Clinical Study Protocol, Clinical Data Management Plan, Data Analysis Plan documents.
• Involved in creating of domains based on SDTM IG for the Oncology domains TU,TR and RS.
• Data transmission and integrity check of the SAS datasets.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Tools, SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
• Produced quality customized reports by using Proc tabulate, Proc report and Proc summary and also provided descriptive statistics using Proc means, proc freq, and proc univariate.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Integrated SAS datasets into Excel using Direct Data Exchange, using SAS to analyze data, statistical tables, listings and graphs for reports.
• Participated in study locks by doing the final analysis of the data and reports. Followed validation process for all the IT systems created.
• Prepared Data Definitions for the studies.
• Developed and implemented complex oracle backend programs by using SQL, PL/SQL
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Reviewed of Clinical data for FDA Submissions.
• Involved in the preparation of Clinical Study Report (CSR) Using split plot ANCOVA design.
• Performed analysis by using SAS procedures such as Proc means, Proc UNIVARIATE, and Proc Plot in SAS/STAT, SAS/SQL.

Environment: SAS 9.1, SAS/Base, SAS/Macros, SAS/SQL, Windows XP.

Confidential, Parsippany, NJ

Clinical SAS Programmer

Responsibilities:

• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros.
• Provide SAS programming expertise in the production of the derived datasets, tabulations, graphics, listings, and cross-study summaries from clinical trial data.
• Developed specifications for database in CDISC format and involved in programming datasets in CDISC format
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis, and Report generation.
• Review Clinical Study Protocol, Clinical Data Management Plan, Data Analysis Plan documents.
• Perform data pre-processing and dataset preparation for particular statistical analysis, including checking data quality, handling missing value and duplicate key, clean-up duplicate records.
• Produced quality customized reports by using PROC REPORT and provided descriptive statistics using PROC MEANS, PROC FREQ, PROC UNIVARIATE, and PROC TABULATE.
• Created SAS transport files for Electronic Submission.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/TOOLS, SAS/BASE, SAS/MACRO and SAS/GRAPH, SAS/SQL, SAS/ACCESS.
• Retrieve clinical and lab data from Oracle database and generate SAS datasets. Present results to clinical study team.
• Developed SAS macros for data cleaning and Reporting and to support routing processing using SAS to analyze data, statistical tables, listings and graphs for reports.
• Participated in study locks by doing the final analysis of the data and reports.
• Pulled out data from the clinical database and prepare customized analysis datasets for specific reporting needs.
• Reviewed the Clinical data for FDA Submissions.
• Involved in the preparation of Clinical Study Report (CSR) Using split plot ANCOVA.
• Performed analysis of datasets by using SAS procedures such as Proc Means, Proc UNIVARIATE, and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.

Environment: SAS 9.1, SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, Windows XP, and MS Access

Confidential, St. Paul MN

SAS Programmer

Responsibilities:

• Create SAS datasets, tabulations, graphics, and summaries from clinical trial data.
• Create SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
• Create SAS analysis datasets for statistical analysis.
• Review clinical study protocols, data management plans, Case Report Form (CRF), and other data management related documents.
• Manage data transfer and archival.
• Created SAS datasets using SAS/ACCESS to access remote clients.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macro, SAS GRAPH, SAS/SQL, and SAS/Access.
• Involved in writing SAS code for data management and reporting, and performed validation, including testing SAS code.
• Met with SAS Developer/Bio Statistician/Clinical Data Coordinator/Clinical Data Manager/Clinical Research Coordinator for clinical trial protocol reviewing, Clinical Data Management Plan reviewing, and Clinical Study Report submitting.
• Coded SAS macros to create tables, graphs and listings.
• Produced quality data analysis reports by using Proc TABULATE, Proc REPORT, and PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.

Environment: SAS/Base, SAS/GRAPH, SAS 8.2, MS Excel, Windows XP

Confidential, Durham, NC

Clinical SAS Programmer

Responsibilities:

• Responsible for analyzing data received involving in data management and validation.
• Writing and developing SAS reports to display results.
• Performing integrated summaries and electronic submission activities.
• Create SAS datasets, tabulations, graphics, and summaries from clinical trial data.
• Create SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
• Create SAS analysis datasets for statistical analysis.
• Review clinical study protocols, data management plans, Case Report Form (CRF).
• Import data from Excel files into SAS, check and clean up the data and save as SAS datasets by using datasteps,ProcSort,ProcFreq, ProcMeans, SAS/BASE and SAS/ACCESS.
• Manipulate data by using SAS steps and procedures such as Merge, Stack, sub-set, Proc Transpose, Proc Sort, Proc SQL, Proc Format, Proc Freq and Proc Means in SAS/BASE, SAS/SQL.
• Using split plot ANOVA design do analysis by using SAS procedures such as Proc means, Proc UNIVARIATE, Proc GLM and Proc Plot in SAS/STAT, SAS/SQL and SAS/BASE.
• Create report and presentation by using Proc Report, Proc Plot in SAS/BASE, SAS/GRAPH and SAS/ODS.
• Manage data such as check data validation. Find missing value, duplicate key and duplicate records, then fixed and cleaned up them as well as create cleaned datasets for reporting and analysis.
• Make SAS programs to create summary reports table to show each group how to involve in baseline, or change from baseline for the treatment in 4, 8, and 12 weeks by using Proc MEANS, Proc FREQ and Proc GPLOT in SAS/Macro, SAS/SQL. SAS/ODS and SAS/GRAPH.

Confidential

Clinical SAS Programmer

Responsibilities:

• Creating datasets using SAS/ BASE.
• Involved in providing programming support for Clinical Data Coordinators and Statisticians, and data analysis support generating Datasets and Reports for pharmaceutical studies.
• Produced datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE.
• Prepared the data according to client requirements using data management procedures.
• Developed SAS programs for Edit checks.
• Generated Reports for presenting the findings of various statistical procedures using ODS.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Used the SAS Macro facility to produce weekly and monthly report.
• Designed, formatted and customized style, templates and the layout as per the company requirements in accordance with the FDA guidelines.
• Provided Documentation support for the submission of the datasets according to the CDISC standards.