SUMMARY

• Statistical Programmer with nearly 8 years of SAS programming experience in Pharmaceutical and Contract Research Organizations with emphasis on analysis, development, validation and implementation of various projects.
• Working noledge on different phases of Clinical Trials (Phase I - III).
• Creating SDTM,ADaM datasets and their validation, Open CDISC Validator, EDC
• Mapping Specifications, standardize the data values using CDISC Controlled Terminology(MeDRA aFnd WHO), Define.xls
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Extensive noledge in SAS tools like SAS/Base, SAS/SQL, SAS/Macros, SAS/Graphs, SAS/Stat and SAS/ODS. Knowledge on Data ware house concepts.
• Experienced in importing and exporting Data from SAS,
• Knowledge on Hadoop and Core Java
• Good noledge on SAS Visual Analytics
• Created and maintained SAS macros and utilities.
• Good noledge of CDISC Standards
• Extensive experience in data analysis and reporting.
• Experienced with good noledge on clinical trial phases, clinical protocols, CRF’s/Annotated CRF’s, ICH, and GCP guidelines.
• Proficient in handling multiple projects.
• Excellent analytical and problem solving skills.
• Experienced in independently and TEMPeffectively organizing and managing multiple assignments with challenging timelines

TECHNICAL SKILLS

SAS: SAS BASE/MACROS, SAS/Access, SAS/GRAPH, SAS/SQL, SAS/ODSSAS/STAT, SAS/REPORT, version 9.1.1/9.1.3/9.2

OS: Windows XP/7, Unix

Database: Sql, Oracle, MS Access

Office Tools: Ms Office, Outlook, Adobe acrobat

Programming Language: SAS, SQL, PL/SQL

PROFESSIONAL EXPERIENCE

Confidential, CA

SAS Programmer

Responsibilities:

• Responsible for the creation of analysis datasets and clinical study report displays
• Involved with the validation of analysis datasets, tables and listings
• Generated Tables and Listings as per the specifications of display templates
• Generated RTF and PDF reports, using SAS - output delivery system(ODS)
• Experienced in mapping the datasets and creating CDISC (SDTM and ADaM) datasets as per the specification, Validation of the SDTM and ADaM datasets, and Define.xls
• Involved in CRT's (Case Report Tabulations) and listing reports using Study Data Tabulation Model (SDTM) Model.
• Updated the standard macros based on the requirements
• Created utility macro to randomly select sites and subjects and provide the list for the clinical for further monitoring of subjects
• Proficient in indicating the input data sets, setting, sorting and merging techniques to get the required report.
• Involved in writing the SAS codes to halp in the process of Quality control by implementing various statistical procedures like FREQ, MEANS, UNIVARIATE, SUMMARY, TRANSPOSE, SQL, and PRINT
• Debugged SAS programs using PUT, Data NULL statements in code reviews and testing.
• Involved in maintaining appropriate study application documentation.

Confidential, CA

SAS Programmer

Responsibilities:

• Developed and documented programs to create datasets, tables and listings for Phase II and III clinical trial data.
• Created SDTM datasets based on the SDTM Implementation guide.
• Performed SDTM Validation Checks.
• Creating Analysis datasets for safety and efficacy analysis according to SAP.
• Involved in validation of Datasets, Tables and Listings created by fellow programmers.
• Created datasets and performed validation before report generation using base SAS Programming.
• Responsible for accurate and timely data analysis and submission.
• Created tables and listings according to the Statistical Analysis Plan (SAP).
• Created reports used for the analysis as primary programmer and also validated the reports as secondary programmer.
• Solid understanding of FDA medical device standards and implementation of device regulations.
• Gained experience in analyzing various efficacy and statistical procedures.
• Experienced in using company global macros for reporting procedures.
• Created Sensitivity and Specificity tables as per the study procedure.
• Established and maintained libraries of fully documented and validated SAS programs/ macros / procedures which are used and recycled.
• Worked closely with statisticians to resolve data issues with the clinical trial data.
• Communicated with Statisticians about various TLG specifications related issues.

Confidential, CA

SAS Programmer

Responsibilities:

• Extraction of data from Oracle, Teradata datasets.
• Performing data validation, transforming data from RDBMS oracle to SAS datasets.
• Transformations using Base SAS Procedures and Functions.
• Responsible for the cleaning, reformatting, analysis and loading the data into the database.
• Developed new or modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Produced RTF, CSV, PDF and HTML formatted files using SAS/ODS to produce reports for presentation and further analysis.
• Working major enhancements on Unix shell scripts for SAS batch programs
• Developed loss prediction model using Enterprise miner modeling solutions and SAS procedures.
• Created and delivered reports and presentations with key findings and recommendations.
• Provided technical support on SAS programming related to data manipulation and analysis.
• Exported SAS Reports to the Excel Sheet by using ODS/Tagsets/ExcelXP to get the output in multisheets.

Confidential

Statistical SAS programmer

Responsibilities:

• Collaborated with Biostatisticians and Clinical Research Scientists on studies and halps define the analysis datasets.
• Used internal macros and developed own macros to automate statistical table, figure, and listing production.
• Reviewed draft and final production runs for projects to ensure quality and consistency.
• Ensured dat the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
• Generated analysis datasets according to CDISC standards.
• Provided statistical data analysis and programming support for oncology studies.
• Created statistical tables and listing summaries and graphs.
• Developed project-related solutions to the full scope of statistical programming tasks.
• Created and maintained standard SAS format libraries, macro libraries, and common program libraries.
• Experienced in creating and handling the techniques according to the SOP’s.
• Assisted in the preparation of submissions of electronic data to regulatory agencies.
• Planned and established programs for data transfers, dataset generation, analysis programs, and for QC and validation.

Confidential

Statistical SAS Programmer

Responsibilities:

• Provide statistical programming support for programming requests for several studies in close collaboration with Statisticians.
• Collaborated with project teams to complete scientific reports and review reports to ensure accuracy and clarity.
• Ensured the validation and quality assurance of the output.
• Provided statistical data analysis and programming support for the studies.
• Worked with Statisticians on Data Integration for efficacy and safety tables.
• Integrated data from multiple studies for ISS and ISE.
• Involved in discussions regarding integrated analysis variables.
• Analyzed raw data and provided input to statisticians regarding analysis dataset specifications.
• Responsible for the proper coding, documentation and validation of SAS programs/macros/procedures to produce the standardized data display.
• Performed verification of SAS-generated outputs (table, listings and graphs) via independent programming.
• Established and maintained libraries of fully documented and validated SAS programs/ macros / procedures which are used and recycled.
• Ensured proper and consistent implementation and maintenance of guidelines and standards within the department.
• Involved in generating various e-submission deliverables for the FDA.
• Demonstrated excellent problem solving skills, and willingness to take decisions on regular basis.

Confidential

Statistical SAS Programmer

Responsibilities:

• Created Analysis Datasets, Tables, Listings and Graphs as primary programmer and validated as a secondary programmer.
• Developed Programs to generate Exceptional Reports, Sponsor Listings to identify data issues.
• Involved in day to day activities related to SAS Programming and Performed Validation checks.
• Converted SAS data sets to various file formats such as HTML, PDF, RTF, EXCEL etc. using SAS/ODS and PROC EXPORT.
• Created variable metadata, value metadata, dataset metadata spread sheets for E-Submission to FDA.
• Carry out all activities according to SOPs.
• Served as a resource for technical solutions for SAS & IT related problems.
• Built complete format libraries for various studies.
• Ensure adherence to programming guidelines.
• Documented all Programs for accurate historical record and future reference.
• Demonstrated excellent problem solving skills and willingness to take decisions on regular basis.