SUMMARY

• 8+ years of strong experience as SAS Programmer in clinical domain.
• Extensive experience in various therapeutic areas like Diabetes, Cardiovascular, Antiulcerants, CNS, Analgesic, dermatology, endocrinology and Vaccines etc.
• Implementing CDISC standards to clinical trial data through converting raw datasets to SDTM datasets with reference of mapping documents prepared by following SDTMIG.
• Good experience in Clinical Trials, Clinical Data Analysis, Clinical Data Migration, generating Statistical Analysis files, Tables, Listings, Graphs, Validations, documentation.
• Strong experience in Base SAS, SAS/SQL, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/MACROS in windows environment, and UNIX
• Experienced in Data Management tasks such as data extraction, data validation, data manipulation, data processing, data transformation, data cleaning and data loading.
• Involved in creating ADaM’s and population datasets.
• Experienced with DMC statistics and TLFs.
• Creation of new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Update, and Conditional statements.
• Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spread sheet, Microsoft Excel, oracle and Access tables.
• Extensive programming experience with procedures like SQL, SORT, Regression, REPORT, FORMAT, FREQ, MEANS, TABULATE, TRANSPOSE etc.
• Proficient in using formats and informats, update, loops, arrays and conditional statements for appropriate analysis and created markups as per specification.
• Experienced in generating reports (outputs) with report procedure and data null .
• Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.
• Strong knowledge of clinical trials methodology, ICH - GCP, GPP, USA FDA and 21 CFR Part 11 guidelines, WHODrug, MedDRA.
• Maintained documents adherent to SOP (Standard operating procedures) and programming standards.
• Assisted in generating Annotated Case Report Form (CRF) design and development.
• Creation, modification and maintenance of SAS catalogs, and developed, maintained and documented of SAS programs and macro libraries.
• Ability to work independently and very good team player with excellent communication, analytical and problem solving skills.

TECHNICAL SKILLS

SAS Versions: SASV9.1.3, SAS 9.2

SAS Tools: Base SAS, SAS/SQL, SAS/MACROS, SAS DM, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/CONNECT

Reporting Tools: MS Excel, MS Word.

Databases: Oracle, MS-Access

Operating systems: Windows, UNIX.

PROFESSIONAL EXPERIENCE

Confidential, Rochester, MN

Sr. Clinical SAS Programming Consultant

Responsibilities:

• Work in Phases of clinical trials for heart diseases and diabetes.
• Design and implement statistical reporting processes for clinical data analysis.
• Extensively use SAS/SQL and UNIX facility to provide reusable programs that can be conveniently used time to time and created tables, listing and graphical reports..
• Generate output files in text format, HTML & PDF format using SAS ODS.
• Create SAS transport (.xpt) files and converted the Transport files into SAS Data Sets.
• Use SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Develop reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Design 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.
• Develop SAS programs for listing of tables for data review and presentation including adhoc reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.
• Create CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.
• Perform 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.
• Maintain documents adherent to SOP (Standard operating procedures) and programming standards.
• Coordinate the production of monthly, quarterly, and annual performance reports for senior management.
• Experienced with DMC statistics and TLFs.
• Establish and maintain a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Database personnel.

Environment: Windows, SAS 9.1, SAS/BASE, SAS/STAT, SAS/MACROS.

Confidential, San Diego, CA

Clinical SAS Programmer

Responsibilities:

• Reviewed and acquired knowledge about documents related to clinical trials like Clinical Protocol, SAP, Clinical Study Report and a CRF (Annotated CRF).
• Imported raw data sets and converted it to SDTM standards as per CDISC SDTM 3.1.2V.
• Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Derived analysis datasets as per derived dataset specification.
• 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.
• Used SAS ODS to produce HTML, PDF and RTF format files.
• Successfully validated study TLG’s and CRT’s through independent validation using Proc compare and departmental standard macros.
• Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Performed Quality Assurance procedures for existing programs including Validation and Debugging of complex codes
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Actively participated in internal QA peer reviews and managing the project folders on project shared drive and SharePoint site

Environment: SAS 9.1.3V, Unix, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ACCESS, SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/CONNECT, MS-Excel, MS-Access

Confidential, St. Petersburg, FL

Administrator SAS

Responsibilities:

• Responsible for enterprise-wide administration, design, and support of third party Business Intelligence software including, but not limited to: SAS and Hyperion.
• Provided support to internal SAS customers working in U.S. SAS allows access to a petabyte of Netezza data from a farm of 20 AIX UNIX servers. Netezza houses 136+ production & test databases.
• The primary focus was utilizing advanced functions within BI tool suites to gain optimum efficiency and accuracy. We use the latest version, 9.2 M3, of SAS with Enterprise Guide (EGuide), SAS Management Console (SMC), Data Integration Studio (DIS) & SAS Add-In for Excel.
• Constant monitored on the “Issue Report” we provide support to customer/analysts immediate needs in SAS (9.3 - EGuide4) and Hyperion (11) as well as initial setup and assignment of these business Enterprise solutions.
• Involved in Developing, Debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• Created SAS customized reports using PROC TABULATE, PROC REPORT and DATA NULL
• Utilized standard company macros and modified SAS programs for creating tables and listings.
• Created custom views combining data from multiple CRF’s.
• Generated Ad-hoc reports for analyses using SAS tools for in the oncology therapeutic area.
• Created SAS Macros and modified the existing ones relating to multiple studies.
• Produced Tables, Listings and Graphs from Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Analyzed credit report to determine credit worthiness and performing risk evaluations.
• Ensured loans are structured and priced consistently with bank policy and commensurate with risk.
• Analyzed and calculating debt to income ratio for evaluating mortgagor’s financial risk and provide recommendation to mortgagor to lower debt to income.
• Evaluated and recommended affordable options to mortgagor to help reduce financial loss.
• Run daily report to help determine how many loans are in foreclosure or will be in foreclosure within the next ten days.

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

Confidential

Clinical SAS Programmer/Analyst

Responsibilities:

• Conceptualized Clinical trials phase II and III through SAS programming by providing statistical support to Statisticians and Biostatisticians.
• Tables, Listings and Graphs were created successfully using Proc Report, Proc Tabulate, Data Null, Proc Plot and Proc GPlot.
• Existing datasets relating to multiple studies was modified using SAS Macros.
• Created CRT (Case Report Tabulations) datasets using ODM model of CDISC standards for FDA Submission.
• Developed Tables, Listings and Graphs from Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Processed Quality control by creating SAS codes using various statistical procedures such as Proc Freq, Proc Means, Proc Univariate, Proc Summary, Proc Transpose, Proc SQL and Proc Print.
• Successfully validated TLG’s and CRT’s through independent validation using Proc Compare and standard Macros.
• Maintained appropriate study application documentation.
• Program documentation on all programs, files and variables was performed for accurate historical record and also for future reference.
• Optimized performance of Clinical trial data using data cleaning and data validation.
• Wrote Customized Safety and Efficacy Reports directing SAS output to RTF and HTML files using Output Delivery System (ODS) facility.
• Integrated Data from wide range of sources including in-house clinical data management systems, labs and contracted research organizations and performed data cleaning with data steps using DLM, DSM, TRUNCOVER, MISSOVER etc.

Environment: SAS 9.1.3 Windows, SAS/BASE, SAS/MACROS SAS/ODS, SAS GRAPH, SAS STAT and MS-Excel.

Confidential

Clinical SAS Programmer

Responsibilities:

• Reviewed and provided input to documents such as eCRF,RAP outline, analysis dataset and display specifications and QC record.
• Performed statistical and data analysis, generated reports, graphs and listings using SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL and SAS/ACCESS.
• Worked with the Clinical Data Management Group to design or review database structures.
• Integrated data from different studies and contributed in the preparation of Integrated Summary of Safety (ISS) for clinical studies.
• Developed routine MACROS to create Tables, Listings and Figures (TLF’s).
• Used DATA NULL technique for reporting outputs.
• Produced quality customized reports using TABULATE, REPORT and SUMMARY procedures and also provided statistics using procedures for MEANS, FREQ and UNIVARIATE analysis.
• Built new MACROS and modified existing MACROS to produce customized graphs using statistical procedures like PROC GPLOT and PROC GREPLAY to include in reports that required FDA approval.
• Responsible for QC of derived datasets and statistical results produced by other statisticians.
• Created HTML and RTF reports using SAS Output Delivery System (ODS).
• Contributed to Case Study Reports (CSR) and documents to be submitted to FDA.
• Derived from specifications of survey regarding editing, coding, reports, debugging etc.
• Accompanied inPhase I various consulting sessions and provided support in statistical analysis including choice of experiment design, management of data, statistical procedures for analyzing experiments, interpretation of the results, statistical modeling and statistical computing.

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