SUMMARY

• Sr. Statistical Programmer/Analyst with over 6 Years of experience in developing and generating TLG by referring to CRF, Statistical Analysis Plan (SAP) & Mockup Shells in accordance with Standard Operating Principals (SOP), Development of Analysis datasets from Data Definition Tables (DDT), developing Macro programs and Validation.
• Worked with Statisticians, Medical Writers and Project Managers to provide SAS programming in analyzing teh data, generating reports, tables, listings and graphs.
• Created SDTM datasets from Raw Data sets by following Annotated CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS - SQL, SAS ODS in Windows and UNIX environments.
• Adept in various study designs, Parallel Group, Cross Over and Extension studies.
• Hands on Experience in Phase I, II & III clinical trials.
• Worked with different clinical trials safety data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory and Concomitant in different therapeutic areas viz., Cardiology, Oncology, Infectious Diseases (Skin) etc.
• Good working knowledge on Safety and Efficacy domains of Clinical Trials.
• Basic knowledge of coding dictionaries such as MedDRA, WHODRUG.
• Dataset Creation and Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Developed numerous Ad Hoc reports as required by medical writers and FDA.
• Assisted in programming and documentation for regulatory submissions.
• Excellent oral and written communication skills. A quick learner with an eye for detail and excellent analytical and quantitative skills.

TECHNICAL SKILLS

SAS Tools: SAS V 9.1, 9.2, 9.3, Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS.

Operating System: Windows 95/2000, Windows XP, UNIX.

Software: MS Word, MS Excel, Excel VBA, MS Access, MS PowerPoint.

PROFESSIONAL EXPERIENCE

Confidential, MI

Clinical SAS Programmer

Responsibilities:

• Extensively programmed in SAS/Base, SAS/Macros, SAS/Graph and SAS/Report.
• Developed Tables, Listings, and Graphs to access Safety and Efficacy data during Phase I-III trials on Randomized, Blinded Open Label Studies.
• Develops and validates CDISC compliant SDTM and Adam datasets.
• Develops, validates, and maintains clinical trial databases and data entry screens using SAS and related software.
• Reviewed Edit checks to report teh incorrect data to data management group.
• Provides programming needs to support client’s requirements.
• Validated teh Analysis datasets, Tables and listings by Independent parallel programming.
• Wrote and Validated SAS programs to generate appropriate listings ( inc. patient profiles) and reports to support data cleaning.
• Worked on creation of Annotated CRF’s.
• Created define.xml files for teh FDA submissions.
• Imported and converted Text Based Data files into SAS Data Sets for analysis.
• Involved in generating teh IND reports (ISS & ISE) as per teh requirements from Statistician and SAP.
• Create tables for ad-hoc requests and submission for all areas like safety, efficacy, lab, demographics etc.
• Worked on analysis data definition document and transport files for FDA submissions.
• Represented Statistical programming team in review meetings.
• Extensively used PROC Print, Proc Tabulate and PROC Report to create reports and used SAS/ODS for generating reports in different formats like PDF, HTML and RTF.

Confidential, Cambridge, MA

Clinical SAS Programmer

Responsibilities:

• Performed statistical and data analysis, generated reports, graphs and listings using SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL.
• Analyzed data and produced safety and efficacy tables, figures and listings according to SAP and for regulatory submissions.
• Created adhoc reports as required by FDA or sponsor.
• Mapped raw data into teh CDISC SDTM format.
• Developed specifications for both SDTM and ADaM datasets as per CDISC standards.
• Creating SDTM and Adam data sets on production side and validated datasets developed by other programmers using independent double programming.
• Table Programming for Integrated Summary of Efficacy (ISE) and Safety (ISS).
• Involved in multiple projects and interacted withother SAS programmers, statisticians and data managers to analyze data.
• Supported Clinical Trial studies in reviewing mock shells for TFLs, creating/maintaining SAS programs, performing QC and reviewing documents
• Developed SAS code to clean teh invalid data from teh database while reading teh data from Oracle, Excel into SAS.
• Developed routine SAS Macros to create tables, graphs and listings for Clinical Study Reports and regulatory submissions and maintained existing macros.

Confidential

SAS Programmer

Responsibilities:

• 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
• Analyzed Phase Ι, ΙΙ and ΙΙΙ 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)
• Involved in reviewing of SAP.
• Developed safety and efficacy tables. (Adverse event, Demography, Disposition, Exposure, Medical History, Drug History, Vital signs, Lab and other safety, primary/secondary efficacy endpoint TLF's) using SAP.
• Used teh SAS Macro facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created CRT (Case Report Tabulations) using CDISC standards for submissions to teh FDA.
• Created and maintained SAS Datasets dat are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Reviewed Protocol, SAP, annotated CRF, mapped specifications and other related documents.
• Created derived data sets for safety analysis such as ADAE, ADLB etc.
• Created descriptive statistics using PROC FREQ/UNIVARIATE.
• Created Project specific macros and formats.
• Preliminary data validation (clinical data quality checks) is done on teh clinical trial data.
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/function/procedure for data manipulation.
• Programmed customized data display (including data listing) according to SAP.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures (e.g., Proc Means, Proc Freq, Proc Report)
• Extensive interaction with teh functional users to understand teh requirements on statistical methods and measures.
• Designed flowcharts indicating teh input data sets and teh techniques dat would be used (sorting, merging, etc.) to get teh desired output.
• Generated summary statistics using SAS STAT procedures.