SUMMARY:

• Over 8 years of experience working with SAS and SAS tools emphasizing on analysis, design, developing, testing validating and implementation of various projects for Pharmaceuticals and Clinical Research Organizations.
• Strong SAS Programming experience with statistical background in phase I, II, and III of clinical trials.
• Knowledge of SOPs/Guidelines, ICH - GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical applications.
• Generated ad hoc reports as per the request of Statistician.
• Used Data migration procedures for Importing and exporting data from Excel spreadsheets, Tab DLM, CSV, and any DLM to SAS Data sets.
• Experience with various therapeutics like oncology, CNS, virology, CVS, pain and Respiratory.
• Have Very good experience in Edit checks, PK tables and PK listings..
• Good Exposure to Clinical Trials, Generating Statistical Analysis Files, Tables, Clinical Data Analysis, Documentation
• Conversant with programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA
• Has distinct ability to adopt quickly to new platforms and applications.
• Positive work approach, fast learner, highly motivated, team player with good technical and analytical skills to work independently as well as in team.

TECHNICAL SKILLS:

OPERATING SYSTEMS: DOS, Windows 98/2000/XP/UNIX

DATABASES: MS Access, SQL, Oracle

LANGUAGES: SAS, C, C++, SQL,PL/SQL

SAS TOOLS: SAS/Base, SAS/Stat, SAS/Graph, SAS/Access, SAS/Macro, SAS/Connect, SAS/SQL, SAS/Access

FRONTEND TOOLS: MS Office 2000MS Word, Word Processing, MS Project, MS Excel, SQL tools

WORK EXPERIENCE:

Confidential, Wayne, PA

Sr. SAS Programmer

Responsibilities:

• Developed SDTM Specifications for all the domains including Oncology domains using SDTM IG 3.1.2 & 3.1.3
• Responsible for providing SAS programming for Phase I, II and III clinical studies.
• Involved in QC of SDTM, ADaM, Tables, Listings and Figures.
• Validation of SDTM domains including Findings (LB, VS, PE, QS, PC), Events (AE, CE, MH), Interventions (EX, CM) and other special purpose and Trial design domains.
• Worked on analysis data sets, tables, listings and graphs as per the SAP.
• Performed Validation on derived datasets and following the standard operating procedures during validation procedures
• Involved in TLF mock-shell development, QC of analysis plans, programming specifications, derived dataset specifications, and other process supporting documents
• Validation of ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, ADTR, ADTTE datasets.
• Developing files for electronic submissions to regulatory agencies
• Ability to write some common and utility macros that are useful across multiple studies
• Generated output files in text format, CSV, HTML & PDF format using SAS ODS.
• Worked on various kinds of tables including AE tables and other safety tables like lab tables, vital signs tables and lab shift tables etc.
• Executed program documentation on all programs, files and variables for future .

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros,SAS/ AccessMS-Excel.

Confidential, Wilmington, NC

Sr. SAS Programmer

Responsibilities:

• Involved in programming specifications, derived dataset specifications, and other process supporting documents and also QC analysis plans.
• Performed Validation of SDTM domains including Findings (LB, VS, PE, QS, PC), Events (AE, CE, MH), Interventions (EX, CM) and other special purpose and Trial design domains.
• Responsible for providing SAS programming for Phase I, II and III clinical studies.
• Wrote code to generate CDISC SDTM/ ADaM datasets, and prepared integrated databases.
• Programmed and validated safety datasets and subject level datasets like ADSL, ADAE, ADLB, ADVS, ADTR and efficacy datasets like ADTTE.
• Also worked on PK analysis datasets like ADPC and ADPP.
• Worked on various kinds of tables including AE tables and other safety tables like lab tables, vital signs tables and lab shift tables etc.
• Involved in statistical analysis tables using various procedures like PROC MIXED, PROC ANOVA and PROC LIFE TEST.
• Generated figures including line plots, scatter plots, doc plots, bar graphs, survival analysis plots using various procedures like PROC GPLOT, PROC SGPLOT, PROC SG-scatter, PROC life test etc.
• Generated DM- listings in various formats including RTF, LST, Excel format using different ODS RTF, ODS PDF, ODS tag sets.

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros,SAS/ Access, MS-Excel

Confidential, Pleasanton, CA

Sr. SAS Programmer

Responsibilities:

• Involved in TLF mock-shell development, QC of analysis plans, programming specifications, derived dataset specifications, and other process supporting documents
• Developed SDTM Specifications for all the domains including Oncology domains using SDTM IG 3.1.2 & 3.1.3
• Validation of SDTM domains including Findings (LB, VS, PE, QS, PC), Events (AE, CE, MH), Interventions (EX, CM) and other special purpose and Trial design domains.
• Validation of ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, ADTR, ADTTE datasets.
• Developing files for electronic submissions to regulatory agencies
• Responsible for providing SAS programming for Phase I, II and III clinical studies.
• Worked on analysis data sets, tables, listings and graphs as per the SAP.
• Performed Validation on derived datasets and following the standard operating procedures during validation procedures
• Ability to write some common and utility macros that are useful across multiple studies
• Generated output files in text format, CSV, HTML & PDF format using SAS ODS.

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros,SAS/ AccessMS-Excel

Confidential, Woodcliff Lake, NJ

Sr. SAS programmer

Responsibilities:

• Developed specifications for database in CDISC format and involved in programming datasets in CDISC format (SDTM model 3.1.2) and created ADaM data sets for several studies.
• Verified accuracy and integrity of Clinical data by performing validation checks written in SAS and data cleaning by investigating data related errors and missing values.
• Developed specs for SDTM and ADaM data sets.
• Wrote code to generate CDISC SDTM/ ADaM datasets, and prepared integrated databases.
• Worked in Respiratory, Pain and Cardiovascular therapeutic areas
• Involved in QC of SDTM, ADaM, Tables, Listings and Figures.
• Created tables, listings and figures as per SAP.
• Used SAS Macros for validating programs and generating reports.
• Performed various ad hoc analyses as per guidelines and requests maintaining CDISC standards.
• Extensively used Base SAS (MEANS, FREQ, TABULATE, REPORT, etc.) and SAS/STAT procedures like PROC ANOVA, PROC REG, etc., for summarization, cross-tabulations and statistical analysis purposes and SAS/GRAPH procedures like PROC GPLOT and PROC GCHART to generate reports.
• Generated various documents (Define.xml, Transport files, Data definition Documents) required for the FDA submission.

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros,SAS/ Access, MS-Excel

Confidential, Foster City, CA

Sr. SAS Programmer

Responsibilities:

• Engaged in generating Graphs, Developed and Validated SAS programs and macro codes to produce analysis datasets and reports including non-standard ad-hoc requests.
• Involved in validating TLGs created by other programmers.
• Developed utility macros for standard reports and validation.
• Worked on Respiratory and Diabetic Therapeutic areas.
• Developed reports according to SOP’s by using PROC TABULATE, Proc REPORT, Proc SUMMARY, Proc SQL and also provided descriptive statistics using PROC Means, Proc Freq.
• Involved in e-submissions, submitting data sets in standard format, analysis datasets, Metadata, Annotated CRF, subject profiles and creating define.xml.
• Generated output files in RTF & PDF format using SAS ODS.
• Involved in QC of SDTM, ADaM, Tables, Listings and Figures.

Environment: SAS/Base, SAS/Graph, SAS/SQL, SAS/Macros,SAS/ Access, MS-Excel

Confidential

SAS Programmer

Responsibilities:

• Executed program documentation on all programs, files and variables for future .
• Involved in e-submissions by creating Annotated CRFs, and Transport datasets in .XPT format.
• Experience in producing and validating Tables, Listings and Graphs (TLG’s) using Base SAS, SAS/Graph, SAS/Macros and SAS/ODS according to Statistical Analysis Plan (SAP).
• Responsible for providing SAS programming for Phase I, II and III clinical studies. Created analysis data sets, Tables, Listings and Figures.
• Developed programs for converting the Oracle data into SAS datasets using SQL Pass through facility