Professional Summary

• SAS/Statistical programmer with over 6 years of experience in clinical data analysis and working for Contract Research Organization CRO , pharmaceutical and Biotechnology industries.
• Extensive expertise in handling and processing programs using SAS BASE, SAS/STAT, SAS/MACROS, SAS /ACCESS, etc.
• Excellent in various SAS procedures for data manipulation like Proc Summary, Proc Report, Data NULL , Proc Tabulate, Proc Freq, Proc Univariate, Proc Means, Proc SQL, Proc Transpose, Merge, Proc Sort, Proc Append, SAS Informats /Formats etc. .
• Experience in converting SAS datasets to various types of files like RTF Rich Text Format , HTML and PDF using Output Delivery System ODS and hands on experience in ad-hoc reporting.
• Excellent in performing data transfer activities between SAS and various databases and data file formats like XLS,CSV,DBF,MDB etc.
• Expertise in producing graphs in SAS by utilizing procedures in SAS/GRAPH like proc GPLOT and Proc GCHART.
• Expertise in performing statistical programming as per design specifications for creating tables, listings and figures TLFs and generating Integrated Summaries of Safety ISS and Integrated Summaries of Efficacy ISE .
• Good knowledge of statistical procedures like ANOVA, Correlation, Logistic Regression, Regression Analysis, Survival Analysis etc.
• Good understanding of data standards provided by Clinical Data Interchange Standards Consortium CDISC like Study Data Tabulation Model SDTM , Analysis Dataset Models ADaM and Define.xml, along with experience in data analysis during Phase I, Phase II, Phase III and Phase IV of clinical trials.
• Knowledge of utilizing medical dictionaries like MedDRA during data analysis and good understanding of 21CFR Part 11 for computer validation inspections and electronic submission of New Drug Application NDA to FDA.
• Good knowledge of regulatory requirements in clinical research like International Conference on Harmonization ICH guidelines and Good Clinical Practice GCP regulations.
• Excellent problem solving and analytical skills along with strong verbal and written communication skills and ability to work fairly independently.
• Strong organizing skill with commitment to quality and ability to maintain great working relationship with clients, managers and colleagues.

Technical Skills

PROFESSIONAL EXPERIENCES:

Confidential

Role: SAS Programmer

Responsibilities:

• Worked on clinical trials from Phase I to Phase III and generated reports, graphs and listing in SAS with the help of SAS/SQL, SAS/GRAPH, SAS/ODS.
• Followed Standard Operating procedures SOPs for reviewing and verification of the documents and developed ad-hoc reports as required by the client.
• Performed data analysis using SAS/MACROS, used existing and created new MACROS, and generated weekly/monthly reports using the same.
• Generated reports using Proc Report, Data Null and created tables using Proc Tabulate along with data analysis using procedures like Proc Import, Proc Export, Merging, Proc Format, Proc Sort and validating data using Proc Compare.
• Used SAS/ODS to generate reports in HTML, PDF or RTF formats along with Proc format for applying formats to the report.
• Used statistical SAS procedures like Proc ANOVA and Proc Univariate for generating statistical reports of the data and generated safety and efficacy reports of various studies from Integrated Summary of Effectiveness ISE and integrated summary of safety ISS .

Environment: SAS /BASE 9.4, SAS/Macro, SAS/SQL, SQL Server 12.0, UNIX and Windows 8 NT 6.2

Confidential

Role: SAS Programmer

Responsibilities:

• Extracting data from databases using Libname, Filename and Proc SQL, and manipulated data using Proc Sort, Proc Format, Proc Report, and Proc Tabulate procedures in SAS as requested by the client.
• Utilizing SAS Output Delivery System ODS for generation of output reports in HTML, PDF and RTF formats and generating reports using the same.
• Modifying existing macros and creating new macros that ultimately helps in reducing programming time.
• Utilizing DATA NULL and PUT statements for debugging programs in SAS and using SAS MACROS and SAS ACCESS for modification of datasets according to the client requirements.
• Helped in performing statistical analysis of data using SAS/GRAPH, SAS/GPLOT and SAS/GCHART that ultimately helped in easy interpretation of the data at the user end.
• Used PROC SQL for conversion of ORACLE datasets into SAS datasets and created tables and summaries.

Environment: SAS/Base 9.3, SAS/SQL, SAS/Access, SAS/ODS, SAS/STAT, SAS/Graph, SAS Macro, MS-Excel 2013 v15.0 , MS-Access 2013 v15.0 , Windows 8 NT 6.2

Confidential

Role: Clinical SAS Programmer

Responsibilities:

• Generated Annotated Case report form aCRF from the metadata in accordance with the CDISC and FDA standards.
• Created various clinical study datasets from Phase I and Phase II in accordance with the CDISC requirements and generated documents associated with it.
• Worked on merging electronic data with CRF and generated Data Definition Documents DDDs using SAS/MACROS for New Drug Application NDA submission.
• Utilized Proc Freq, Proc Means, Proc Report, Proc Transpose, Proc GPlot and Proc GChart procedures for the generation of Tables, Listings and graphs TLGs in accordance with SOPs and Statistical Analysis Plan SAP .
• Developed and reviewed SAS programs and output for the management and reporting of clinical trial data. Utilized SAS based systems to assist and facilitate Clinical Data Management activities.
• Validated, edited, debugged, wrote SAS code and manipulated datasets using standard SAS procedures like Merge, Proc Sort, SAS functions and Proc SQL.
• Generated and documented Tables, Figures and Listings TFLs for any updates during the clinical trial study process. Also performed changes to the TFLs before Data Review Meeting and Pre-Lock Meeting.
• Performed QCs on TFLs for ensuring their standard and accuracy for meeting client specifications and provided feedbacks as requested.

Environment: SAS Base 9.3, SAS Stat, SAS SQL, SAS Graph, SAS Access, SAS Macros, MS-Excel 2010 v14.0 , Windows 7 NT 6.1, Linux 5

Confidential

Role: SAS Programmer/Analyst

Responsibilities:

• Moving SAS datasets from UNIX to Windows environment and double checking the standardized report generation after migration of the datasets.
• Creating, modifying and maintaining data using SAS procedures like Proc SQL, Macros, Proc import, Proc export and other default SAS procedures.
• Generating reports and analyzing data from patients, audits, and claims using statistical analysis in SAS with the help of procedures like Proc ANOVA, Proc Univariate, and Regression Analysis etc.
• Analysis and modification of existing SAS code for better performance. Generating weekly and monthly reports using Proc report and updating Coventry Data Warehouse.
• Reading files like Excel, .csv, ASCII,.mdb into SAS datasets using import procedures in SAS and loading data into the Coventry Warehouse.
• Extracting, merging, manipulating healthcare data in SAS for better analyses of huge datasets.

Environment: SAS/ BASE 9.2 9.3, SAS Enterprise guide 4.3, SAS/Macro, SAS/SQL, MS Visio 2010 v14.0 , Oracle 10g/9i, SQL Server 10.50 , UNIX and Windows 7 NT 6.1

Confidential

SAS Programmer

Responsibilities:

• Programming and pulling reports using SAS/REPORT as requested by the client and market researchers. Utilizing Proc SQL for creating tables in SAS.
• Working in SAS Windows environment and migrating data from various databases into SAS datasets.
• Performing year end SAS reporting for regulatory studies using Proc Report and utilizing default SAS procedures for data analysis.
• Utilizing ODS for generation of PDF, RTF format file and generating graphs and plots using SAS/GRAPH, SAS/GPlot and SAS/GChart.

Environment: SAS/Base 9.2, SAS/GRAPH, SAS/SQL, SAS/MACRO, Windows 7 NT 6.1

Confidential

Role: SAS Programmer

Responsibilities:

• Involved in performing data exploration and descriptive statistical analysis using SAS and Enterprise Miner.
• Generating reports like final forecast and summary using summarization procedures and Proc Report in SAS.
• Involved in SAS programming using Macros for creating reports, developing datasets for making them ready for analysis and analyzing them.
• Creating charts in SAS using Graph procedures like SAS/GPlot and SAS/GChart for quality control and performance review of facilities.
• Building forecast models using Forecast studio for pricing and demand and creating relational databases.

Environment: SAS Base 9.2, SAS/STAT, SAS Macro, SAS Enterprise Miner 6.1, Forecast studio 3.1, SAS/Graph, MS-Excel 2007 v12.0 , Windows XP NT 5.1