SUMMARY

• Five Years of Programming experience in SAS (Base, Macros, SQL, and Data Steps) in Windows and UNIX.
• Knowledge in conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR Part 11) for Clinical Trial Systems.
• Expertise in various SAS procedures such as Proc Tabulate, Proc Univariate, Proc Transpose, Proc SQL, Proc Freq, Proc Mean, Proc Summary, Proc Contents, Proc Sort and ODS.
• Excellent Interpersonal skills with capable of handling multiple tasks and priorities, self - motivated, displays initiative. High ability to understand and quickly apply new technologies and information. Ability to meet time schedules.
• Excellent written and verbal Communication skills.
• Excellent client facing skills, outstanding analytical skills with attention to detail and a focus on system issues.
• Having very good experience in problem solving, troubleshooting and debugging.
• Ability to work under pressure, meet deadlines and easy to adapt Advanced Technologies.
• Strong experience of SAS Base, SAS Stat, SAS Macros, SAS Graph.
• Extensive experience in preparation of reports, tables, listings and graphs.
• Has extensive experience in Data collection, design, analysis and development of systems.
• Has good experience in using MS Excel, MS Word, MS outlook and other Microsoft Products.

TECHNICAL SKILLS

Programming: SAS, Base, Macros, STAT, SQL, ODS, Java, C, C++

Operating System: Windows 95/98/2000/XP, UNIX

Report Tools: SAS

Database Tools: SQL

PROFESSIONAL EXPERIENCE

Confidential, Hawthorne, NY

SAS Programmer/ Analyst

Responsibilities:

• Used Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS and Excel.
• Data extraction from Oracle Clinical and convert them to SAS data sets. Converted ORACLE data tables into SAS data files using SAS SQL ‘Pass Through Facility,’ and uploaded SAS data files into ORACLE.
• Responsible for standardizing the data usage according to edit checks, performing analysis and loading the data to the database for reporting.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.
• Created complex and reusable Macros and extensively used existing macros.
• Developed SAS programs for data cleaning, validation.
• Developed SAS reports using DATA NULL steps and wrote to External Files.
• Ran several SAS procedures including Summary, Correlate, Graphics, Tabulate, and means.
• Generated ad-hoc reports for raw datasets using Print and Report procedures.
• Delivered data dumps for Clinical Data Management before database lock.
• Experience designing, developing and testing SAS program code to efficiently extract, merge and manipulate large volumes of data
• Developed safety listings, tables and graphs for clinical study team and bio-statistical team review.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans. Review and acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).
• Created SAS data sets by accessing remote clients by SAS CONNECT and SAS ACCESS.
• Extracted data from DB2 database by using SQL procedures.
• Worked with Clinical Data Management team for creating annotated CRF.
• Extensively involved in creating safety and efficacy tables, listing and figures.
• Performed Quality Checks on the existing table, listing and figures.
• Extensively used company standard macros for effective and efficient outputs for clinical trials. Created study specific macros for better performance.
• Hands on Experience in developing mock-up tables referring CRF, SAP
• Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the work progress and queries regarding Project.
• Involved in maintaining QC Documentation.

Environment: SAS 9.0, SAS/MACROS, SAS/SQL, SAS/Graph, SAS/STAT, MS Office

Confidential, Burlington, MA

SAS Programmer Consultant

Responsibilities:

• Experience designing, developing and testing SAS program code to efficiently extract, merge and manipulate large volumes of data.
• Developed SAS programs listings/graphs to create study specific datasets, which were used as source data sets for report generation.
• Used ODS in order to generate PDF, RTF files out of listings and tables being created for daily and weekly data loads.
• Generated derived data sets for the statistical analysis as per SAPs.
• Developed Macros for performing edit checks, and generating Alert and Error message where ever is needed and prepare SAS data sets for Statistical and analysis and reports generation.
• Developed analysis plans including specs for tables, listing, graphs and validation plan.
• Worked on pre-specified statistical tables, figures, and reports for publication.
• Developed listings, tables and graphs for efficacy and safety of clinical studies.
• Created reusable Macros and developed SAS Programs for Data Cleaning, Validation and Analysis and Report generation.
• Developed procedures to standardize analysis programs, including a macro library.
• Used Dynamic Data Exchange (DDE) feature of SAS for importing data from SAS, MS Access and Excel.
• Retrieved ORACLE tables with Proc SQL ‘Pass Through Facility’.
• SAS was used for pre-processing data, SQL queries, data analysis, generating reports, and statistical analyses.
• Create and extract Oracle tables from SAS and within Oracle by using SAS/ACCESS
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Tested and debugged existing macros.
• Developed Edit Check programs to clean invalid data from the database.
• Created SAS reports using the Data Null technique and the Proc Report for the NDA submission as per the FDA regulations and company standards.
• Conducted statistical modeling for both Continuous and Categorical data, including linear regression, nonlinear regression, ANOVA, GLM model, repeated measure, nonparametric regression etc.
• Formatted HTML, RTF and PDF reports using SAS output delivery system ODS.
• Write intense QC Documentation.
• Experience designing reporting templates and creating reports illustrating the results of the analytic and programming processes.

Environment: SAS/BASE, SAS/MACRO, SAS/CONECT, SAS/STAT, Windows, MS Office, MS-Excel

Confidential, Irvine, CA

SAS Programmer Consultant

Responsibilities:

• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
• Extracting data from data warehouse and creating SAS data sets. Converted the clinical trial data, subject records entered in the database files to SAS data sets using SAS/Access.
• Experience working on large scale analysis projects
• Defined variables, merging datasets, creating derived datasets, data need to be validated before processing intensive base SAS programming.
• Prepared new datasets from raw sets files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.
• Extensively used SAS/Base, SAS/SQL, SAS/STAT&SAS/Macros.
• Involved in Validating ISS/ISE Tables and Reporting.
• Developed standard and custom data listing, summary tables, Graphs.
• Validated summary tables, listings, datasets and graphs.
• Created complex and reusable macros.
• Testing and debugging macros.
• Data cleaning and validation.
• Analyzing data according to Statistical Analysis Plan(SAP).
• Generating demographic tables, adverse event and serious adverse event reports.
• Used ODS in order to generate PDF, RTF files out of listings and tables being created.
• Also involved in generating graphs for Efficacy analysis
• Also involved in generating graphs for Safety analysis
• Extensively used procedures like PROC SQL, PROC SUMMARY, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC COMPARE, PROC REPORT, PROC TRANSPOSE and Data null step and other statistical procedures.

Environment: SAS Base, SAS/STAT, SAS/SQL, SAS Macros, SAS/Graph, ODS, MS-Excel, UNIX, and Windows 2000 Server.

Confidential

Clinical Research Coordinator

Responsibilities:

• EC Submission & follow up with EC for Approvals.
• Prescreening subjects for the study
• Reviewing database for identifying subjects for the study
• Assist in informed consent process documentation
• Screening and randomization of subjects
• Ensure source data is complete as per protocol
• Transcribe data to CRF with error free
• Maintaining documentation
• Assist CRA during monitoring visit & audit preparation.
• Maintenance of data query and resolving queries
• Reviews regulatory documents, as required
• Prepares for and attends project launch meetings
• Assists the project team in the tracking of enrollment rates and receipt and review of completed CRFs, as required
• Provides full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials
• Manages query resolution process with sites and Premier Research Data Management
• Ensures adherence to study timeline and budget
• Performs additional duties and assignments as requested.
• To analyze transmembrane proteins using pH, pI and Gross hydropathy index using tools like FASTA, EXPASY.
• Data gathering for different transmembrane proteins.
• Design of protein databases using pH, pI, and space group and detergents used for proteins
• Implemented the best practice for drug molecule
• Implemented different bioinformatics tools such as blast, fasta, nblast
• Assisted researchers in drug modeling using bioinformatics tools