SUMMARY

• Professional with over 7+ years of experience in data analysis using Clinical SAS. Good Command in statistical analysis and research, data management, programming, robust knowledge of Base SAS, SAS/Macros, SAS/SQL.
• Strong knowledge involving all phases (I - IV) of clinical trials.
• Complete knowledge of drug development process, Statistical principles and procedures.
• Expert in the usage of SAS software for data entry, retrieval, management and mining of data.Generate tables of adverse event, demography, laboratory, vital sign, safety dataset, efficacy dataset, Medical history, concomitant medication, Disposition dataset.
• Superior skills in analysing and coordinating data, generating reports, tables, listings, and graphs according to Statistical Analysis Plan, Standard Operating Procedures (SOPs) and departmental guidelines. This involved use of statistical procedures such as REPORT, SUMMARY, EXPORT, GLM, FREQ, TTEST, TABULATE, MEANS, UNIVARIATE, REG, LIFETEST, GPLOT, ANOVA and CORR.
• Proficiency in using various SAS tools like SAS/BASE, SAS MACROS, SAS/STAT, SAS/GRAPH, SAS ODS, CDISC SDTM, SAS/ACCESS, SAS/CONNECT and SAS SQL.
• Experience in debugging, validating and improving on existing SAS programs.
• Knowledge of new drug & device release process from IND submission to FDA approval to post market study, which includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews, risk factor, integrated safety and efficacy summary (ISS & ISE) for FDA submission .
• Knowledge of PROC TTEST, PROC NPAR1WAY, PROC ANOVA, PROC REG, PROC CORR, PROC GLM, PROC MIXED.
• Good understanding of standards specific to clinical trials such as CDISC, SDTM,ADaM,MedDRA, and WHODRUG.
• Experience in developing SAS Programs using Procs, Macros and applications for data cleaning, programming, reporting, and documentation.
• Knowledge of CRT Dataset Creation from clinical trial data.
• Knowledge of CRF-Annotation with respect to various database designs.
• Expertise in analyzing and coordinating clinical data, generating detail and summary reports, and data validation.
• Experience with Data Manipulations, Informats and Formats.
• Experience in developing SAS Procedures, Macros, and application for data cleaning, reporting and involved in preparing documentation.
• Experience with concatenating, interleaving, and merging SAS datasets.
• Able to prioritize work by taking initiative under pressure to meet quality and productivity within the stipulated timeframe to meet the project requirements.
• Good team player with excellent communicational and organizational skills with the will and determination to succeed.

TECHNICAL SKILLS

SAS: Base/SAS, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/Access, SAS/STAT, SAS/SQL, SAS/Report

Databases: Oracle Clinical, SQL Server, MS Access

Programming Languages/ Scripting Languages: C, SQL, PL/SQL, HTML, Visual Basic 6.0, SAS 9.1.3, SAS 9.2, SQL, C, Shell Script

Operating Systems: Windows, UNIX, Linux, Mainframe

Statistical tools: SAS v 9.x/8.x/6.x, SPSS, R/S-Plus

Testing Tools: HP ALM

MS Office: Word, Excel, PowerPoint, Access and Outlook

Business Intelligence: SAS Management Console, SAS Enterprise Guide, SAS Data Integration Studio, SAS Information Map Studio, SAS Web Report Studio

PROFESSIONAL EXPERIENCE

Confidential, San Francisco, CA

Clinical SAS Programmer

Responsibilities:

• Thorough knowledge in SAS Programming, merging SAS Data Sets, Macro Facility, Preparing Data, PROCs, Producing Reports, SAS, SAS Formats, SAS Functions, Storing and Managing Data in SAS Files.
• Developed programs to generate tables and supporting Listings, Integrated Safety Reporting and Electronic Submissions to Regulatory authorities.
• Worked with Data Managers for ensuring the Data Integrity and did Data Cleaning, Data Validation and produced TLG’s as per the requirement of Clinical and Data Management Department (DMD).
• Provided statistical programming expertise in production of Reports, CRT’s (Case Report Tabulation/Analysis Datasets), Graphics, Summaries and Listings from clinical trial data.
• Participated in documentation and data programs archiving.
• Comprehensive skills in working with SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS etc. in windows and Unix environment.
• Contributed to the preparation of Statistical Analysis Plans. Prepared, documented and tested required programs and procedure data displays in an efficient manner for inclusion in integrated clinical statistical reports and other similar reports.
• Created CRT Datasets used for FDA Submissions .
• Good working knowledge in CDISC standards like STDM,ADAM.
• Worked with different clinical trials data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory, and Physical examination.
• Wrote SQL for different conditions.
• Worked closely with Data Management Group to create data cleaning and data validation listings.
• Performed QC, Data Validation and Edit Checks using various procedures and Macro facility.
• Quality assurance checks to support cleaning of clinical data using put statement and various Proc’s.
• SAS Macros were extensively used in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Thorough Knowledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel . Also possess good working knowledge in Internet based access and database Usage.
• Produced ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate .
• Used Data Null technique for producing highly formatted and highly customized reports.
• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation and further analysis.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports.

Environment: Base SAS, SAS/Macro, STDM, ADAM, SAS/SQL, SAS/Graphs, SAS/STAT, SAS/connect, MS-EXCEL, HTML, Windows NT and Linux.

Confidential, North Brook, IL

Senior Statistical Programmer

Responsibilities:

• Worked with a team of Bio-statisticians and Data Managers for Generating Safety and Efficacy tables across Phase I, II, and III Clinical Studies. Good exposure to various Therapeutics areas like Cardiovascular, Oncology and Neurology.
• Generated tables and listings based on CDISC, CDASH SDTM models. Used OpenCDISC to validate the trial data for regulatory submissions.
• Exposed to Medidata Rave functionalities in regard to capturing, managing and reporting clinical trial data.
• Performed data analysis, statistical analysis, and generated reports, listings and graphs using SAS tools-SAS/Base, SAS/Macros and SAS graph, SAS/SQL, SAS/Connect, and SAS/Access.
• Extensively used Proc Export to generate Excel Spreadsheets per Client's requirements from Datasets
• Extract the data from Oracle Clinical and create SAS data sets. Involved in Data Model Preparation, which included drawing of flowcharts, indicating the input data sets, sorting and merging techniques and writing SAS code accordingly.
• Develop programs producing PK/IK CDISC and specialized datasets, tables, listings, and graphics output for early and late development oncology programs.
• Designed, created, and validated new studies in Oracle Clinical. Also, reviewed study documentation, translation of study design parameters into Oracle Clinical data objects.
• Conducted and generated the Regression, Correlation studies and Analysis of Variance (ANOVA) statistical reports.
• Created various graphs such as Bar Charts, Line Plots, Profiles Chart, Scatter plots using SAS/GRAPH
• Good experience in working with various procedures like PROC SORT, PROC MEANS, PROC FREQ, PROC TEST,PROC GPLOT, PROC GCHART and PROC MIXED.
• Created and maintained SAS programs to generate derived datasets and required summary reports for other teams to build ADaM models.
• Quality Control of tables, listings and graphs by double programming or random verification of values.
• Used Integrated Clinical systems like JReview (previously IReview) functionality to review data specific to clinical trials.
• Created Kaplan- Meier Survival plots using PROC LIFETEST and PROC GPLOT.
• Performed adequate testing of new databases in Clinical Data Management Systems.
• Generated various documents (Transport files, Data definition Documents etc.) required for the FDA submission.
• Created reports in PDF, HTML, XML, RTF using ODS statements and proc template.
• Worked with Macro's for generating Tables and Listings.
• Worked closely with clients to review and finalize the Safety and Efficacy Reports.
• Produced Ad hoc reports of various kind, Listings, Tables, and Figures (TLGs/TLFs) using Proc report, proc tabulate, data null technique, proc Gplot etc.

Environment: Windows, CDISC, ALM, SDTM, ADaM, SASV9.1.3, Base/SAS, SAS/Access, SAS/Macro, SAS/STAT, Linux.

Confidential, St. Petersburg, Florida

Clinical SAS Programmer

Responsibilities:

• Produced SDTM and ADaM specifications in accordance with CDISC standards by mapping the annotated variables from CRF’s to the SDTM standard variables.
• Helped European Organization in harmonizing SDTM specifications for therapeutic specific studies.
• Produced SDTM and ADaM domains in accordance with CDISC standards from raw datasets.
• Assisted Statistician’s and company CDISC standard’s team in determining type of SDTM domain for therapeutic specific datasets.
• Made lab specifications for data transfer from central labs.
• Experience in working with extension protocol studies. Generated new datasets by setting together primary and extension datasets.
• Imported data from STC files to SAS datasets using Proc Cimport.
• Produced and validated TLF’s according to SAP and table shell templates using standard macros.
• Reviewed the raw data listings for QA and QC before locking the database.
• Generated PDF files for clinical trial reports and for submissions to FDA.
• Worked on generating interim analyses reports for submitting Abstracts as per statistician guidelines and requests.
• Generated ad-hoc reports in RTF/XLS files using ODS as per the medical writer’s needs.
• Produced patient profiles for medical writing.
• Worked with Statisticians and Clinicians to identify critical variables for the edit checks and QA.
• Experience in working with extension protocol studies. Generated new datasets by setting together primary and extension datasets.

Environment: Windows XP, Oracle8.x, SASV9.1, SDTM, ADaM, Base/SAS, SAS/Macro, SAS/STAT, SAS/GRAPH, Linux.

Confidential

Clinical SAS Programmer

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.
• Expertise in developing datasets with current knowledge, guidance and concepts of SDTM: ex: RELREC, SUPPQUAL, CO domain and generate Define.XML.
• 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.

Environment: Windows NT, ADaM,SASV8.2, Base/SAS, SDTM, SAS/Access, SAS/Macro, SAS/Connect, SAS/STAT, Unix.

Confidential

SAS Programmer

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.

Environment: SAS/BASE, SAS/STAT, SDTM, UNIX, ADaM, and MS EXCEL