PROFESSIONAL SUMMARY:

• Worked on phase I Phase II and Phase III of clinical trials and their designs including open-labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.
• 8 years of highly experienced Clinical SAS programmer
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Connect, SAS/Enterprise Guide, SAS/Stat SAS/Graph.
• Good knowledge of GCP, GPP and US FDA CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well. Experienced in Preparing FDA E-submission ready reporting documentation including creating DDT's, Transport files XPORT format files .
• Experience involved in Statistics and contribution of end to end SAS programming activities data processing, data collection, quantitative and qualitative analysis encompassing extracting data from Clinical trial into SAS as datasets to producing the reports viz. .
• Good understanding of regulatory requirements ,ICH Guidelines, NDA processes, from IND submission to FDA approval in compliance with 21CFR Part 11 . This includes Clinical Trials Phases I-IV , preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary ISS ISE for FDA submission.
• Experienced in transforming raw data into datasets that are in accordance with SDTM and ADAM standards Creation of specifications files for creating analysis datasets, TLGs / TLFs and Ad-hoc reports Develop SDTM data mapping and create SDTM datasets per CDISC standard for FDA.
• Excellent skills in statistical analyses and modeling, familiar with common statistical methods for clinical research and Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials.
• Experience in preparing NONMEM datasets for POPPK analysis and ER parameters EVID, NTAPD, NTAFD, ATAPD, ATAFD, DV another related variables.
• Experience in survival analysis by using procedures like PROC LIFETEST KAPLAN MIER , LIFEREG, PHREG, LOGISTIC.
• Experience in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development SDD .
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results.

TECHNICAL SKILLS

• SAS Skills: v8.0/9.0/9.1/9.2,SAS/BASE,SAS/STAT,SAS/MACROS,SAS/GRAPH,

SAS/SQL, S-PLUS,SAS Enterprise Guide, SAS Enterprise Miner, SAS DI Studio,

SAS Web report studio, SAS/IntrNet, SAS procedures, SAS BI ,open CDISC validation.

• Other Skills: SPSS,R, Qlikview, Sudaan, Strata, S-Plus, MINITAB,MATLAB,ETL tools,

ODBC, health analytics using business intelligence tools, Data

Warehousing, Data Mapping, SharePoint, Sigma Stat, Sigma Plot, MS Office

Power Point, Excel, Access, Word , MS Visio, MEDDRA, ICD-9,ICD-10,

COSTART, EPIC Bridges,HL7, Sarbanes-Oxley, HIPAA.

• Databases: Oracle Clinical, MYSQL, MS SQL Server, MS Access, Oracle 11i, DB2.

• Languages: C,C , Visual Basic, VBScript, XML, T-SQL,SQL, PL/SQL, VB.NET, ASP.NET,

PERL,HTML, PHP, Web CGI.

• Operating Systems: Windows95, 98, NT/XP/2000, DOS, UNIX.

PROFESSIONAL EXPERIENCE

SAS Programmer/Analyst

Confidential

Responsibilities:

• Program, analyze and evaluate clinical data using SAS
• Write edit checks from Data Management Plan specifications
• Act as quality control programmer to validate SAS programs that produce derived/analysis datasets and analyses specified in the Statistical Analysis Plan
• Ensure SAS programs adhere to specifications
• Ensure SAS program output matches the requirements of the Statistical Analysis Plan
• Ensure specifications and documentation are correct and complete
• Assist Data Management in assuring data integrity
• 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.
• Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development SDD
• 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.
• Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL,HTML and Unix.

Clinical Statistical Programmer/Analyst

Confidential

Responsibilities:

• Worked on phase I, II and III clinical trial studies.
• Creation and validation of SDTM datasets from raw data by following SDTM annotations, implementation guide and company standards.
• Creation and validation of ADaM datasets from SDTM datasets as input, implementation guide and company standards.
• Review and proved effective feedback on Protocol, eCRF, database design, Data Presentation Plan DPP , SAP and TLF shells.
• Creation and validation of Tables, Listings and Graphs by following protocol, SAP and shells as per industry and company standards for regulatory submissions.
• Extensively used PROCMEANS, PROC FREQ, PROC ANOVA, PROC REG, PROC UNIVARIATE to create outputs based on SAP and shells for statistical analysis of clinical trial data.
• Assisted in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Used efficient programming techniques to produce and QC derived datasets, tables, figures and data listings.
• Developed and maintained general-purpose and adhoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.
• Reviewed of Clinical data for FDA Submissions
• Retrieve clinical and lab data from Oracle database and generate SAS datasets.
• Created SAS transport files for Electronic Submission
• Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis, and Report generation.
• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros
• Coordinated statistical programming team to successful completion of a study within given timelines and resources.
• Produced Tables, Listings and Graphs from Integrated data of different studies for Integrated Summaries of Efficacy ISE and Safety ISS clinical studies.
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system
• Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL,HTML and UNIX.

Clinical SAS Programmer

Confidential

Responsibilities:

• Analyzed Phase II and III Clinical Trials through SAS programming and by providing statistical support to statisticians and Biostatisticians.
• Created SAS Macros and modified the existing ones relating to multiple studies.
• Successfully created Tables, Listings and Graphs using various procedures like Proc Report, Proc Tabulate, Data null, Proc Plot, and Proc Gplot.
• Created CRT Case Report Tabulations datasets using ODM model of CDISC standards for submissions to the FDA.
• Produced Tables, Listings and Graphs from Integrated Summaries of Efficacy ISE and Safety ISS .
• Effectively and timely contacted data management head of the respective study about the various Data Issues and resolved the queries through meetings.
• Maintained appropriate study application documentation.
• Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development SDD
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Involved in writing the SAS codes to help in the process of Quality control by implementing various statistical procedures like Proc freq, Proc means, Proc uni-variate and other procedures like Proc Summary, Proc Transpose, Proc SQL and Proc print.
• Successfully validated study TLG's and CRT's through independent validation using Proc compare and departmental standard macros.
• Environment: SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/STAT, SAS ODS, Windows.

Clinical SAS Programmer

Confidential

Responsibilities:

• Worked on conversion .XPT files with the data into SAS Data Sets with the SAS Program, PROC COPY IN tran out-raw by select file name. XPT /MEMTYPE DATA, for DEM, ECG, AELOG, DOS SO, ADPAGG, BLEED, CRIT, VISIT and MED.
• Imported and converted PKDATA and PKARDATA .xls files into SAS DATA Sets through SAS Application environment.
• Data transmission and integrity check of the SAS datasets
• Development and maintenance of SAS data and statistical analysis programs to support drug development projects.
• Developed NONMEM datasets POPPK and ER. POPPK data set derived variables in the analysis data are EPID, DOSE N, EVID, ATAFD, ATAPD, and NTAPD. and in ER data set are EPID, PTYPE, and ID. Analyzed the Data and generated the Statistical reports with Graphs for POPPK analysis and ER parameters auc, cmax, tmax, vl, clearance, acc.ratio for the Pharmacologists to analyze the drug performance.
• Wrote code using SAS/BASE and SAS/MACROS to extract data from ORACLE and MS ACCESS databases.
• Using SAS ACCESS defined the oracle database to ODBC to retrieve the data
• Produced quality customized reports using PROC REPORT, PROC TABULATE and SAS/ODS.
• Provided descriptive analysis using PROC MEANS, PROC FREQ, PROC SORT and PROC UNIVARIATE.
• Developed Macros to create tables, graphs and listings for routine reports.
• Provided custom data listings, tables and figures for inclusion in Clinical Study Report CSR documentation.
• Performed statistical analyses using PROC GLM and PROC MIXED following the instructions in Statistical Analysis Plan.
• Combined and Modified SAS datasets for statistical analysis using SAS data step and procedures including PROC SQL
• Create SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.
• Supported Staff programming needs and performed Ad hoc requests.
• Environment: SAS 9.1.3 windows, SAS/BASE, SAS GRAPH, SAS ODS, SAS STAT, MACROS,SQL/PLSQL,MS- Excel, MS-Access.

Clinical SAS Programmer

Confidential

Responsibilities:

• Created CRT Case Report Tabulations datasets using CDISC standards for submissions to the FDA.
• Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets.
• Extensively used Dynamic Data Exchange DDE for importing data in Excel sheets into SAS
• Extracted, validated and generated SAS data sets from Oracle applied 'SQL Pass through Facility'.
• Analyzed Phase I, II and III Clinical Trials.
• Performed statistical analysis, wrote SAS code for Data Management and reporting, and performed validation, including testing SAS code.
• Produced Tables/Listings for Integrated Summaries of Efficacy ISE and Safety ISS .
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations 21CFR Part11, FDA and other regulatory compliance.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures e.g., Proc Means, Proc Freq, Proc Report .
• Experience in survival analysis by using procedures like PROC LIFETEST KAPLAN MEIER , LIFEREG, PHREG, LOGISTIC.
• Extensive interaction with the functional users to understand the requirements on statistical methods and measures.
• Designed flowcharts indicating the input data sets and the techniques that would be used sorting, merging, etc. to get the desired output.
• Exposure to Data warehouse applications.
• Preliminary data validation clinical data quality checks is done on the clinical trial data using SAS/SQL.
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/functions/procedure for data manipulation.
• Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, Oracle 8i, HTML and UNIX.