SUMMARY

• Certified SAS Programmer/Developer with 8+ years of professional experience in clinical trial projects and SAS programming in the CRO’s and Pharmaceutical industries as a SAS programmer.
• Expertise in preparation of reports, tables, listings and graphs, sorting and merging of data validations.
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Experienced in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
• Involved in Design, Development and Implementation of various statistical analysis projects for Pharmaceutical companies.
• Involved in clinical data analysis and preparation of SAS data sets, reports, tables, listings, and graphs according to the Standard Operating Procedures.
• Had good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/QC, SAS/AF and SAS/ETS on windows and UNIX environment.
• Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS formats and In formats, Merging SAS data sets, preparing data, producing reports, storing and managing data in SAS.
• Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
• Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.
• Well experienced in working with different clinical trials data like Demographic, Adverse Events and Vital Signs etc.
• Involved in the process of generating TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Thorough knowledge in Phase I, Phase II, Phase III and Phase IV of clinical trials and single blinded, parallel, cross over, and double blinded studies.
• Hands on knowledge in creating analysis datasets following CDISC, ADAM and SDTM standards for regulatory submissions.
• Review and provide inputs for essential trial documents such as protocol, CRF, Data Management Plan (DMP), Statistical Analysis Plan (SAP).
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).
• Experience in Data manipulation and producing reports employing various SAS procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, and PROC CONTENTS.
• Hands on experience in SAS programming for importing and exporting huge data sets from Flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Experience working with Regression models for comparison of performance metrics.
• Possess a strong ability to adapt and learn new technologies and new business lines rapidly.
• Have excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success in multi - tasking, fast paced environment.

TECHNICAL SKILLS

SAS Procedures/Tools: SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODS, SAS/STAT, SAS/GRAPH, SQL, MEANS, REPORT, PRINT, UNIVARIATE, REG, GLM, CORR, FREQ, SUMMARY, IMPORT, EXPORT, SORT, TABULATE, FORMAT, TRANSPOSE, CONTENTS, ANOVA

Operating Systems: Windows95/2000, Windows XP, MS DOS, and UNIX

Databases: Oracle 8/9i, MS-Access 98/2000/2003, SQL Server, Metadata

Packages: MS Office

PROFESSIONAL EXPERIENCE

Confidential, Greenville, South Carolina

Sr SAS Programmer/Analyst

Responsibilities:

• Responsible for writing SAS programs using SAS/BASE, SAS/SQL, SAS/Macro, SAS/Connect, SAS/Access, SAS/ODS, SAS/STAT and SAS/GRAPH to create SAS reports.
• Created different job in SAS EG, SAS Stored Processes Web Application,SAS DI Studio d, SAS Management Console.
• Created datasets according to client standards.
• Experience in using SAS to read, write, IMPORT and EXPORT to another data file formats, including delimited files, Spreadsheet, Microsoft Excel and access tables.
• Documented all the programs, organized process flow, maintained metadata server, developed macros, graphs and charts using Enterprise guide.
• Experience in coding mathematical expressions in SAS as per the requirement using legacy and new functions.
• Performed Reporting and ETL (Extraction, Transformation and Loading) using BASE SAS.
• Producing reports by employing various SAS procedures like PROC PRINT, PROC REPORT, PROC SUMMARY, PROC FREQ, PROC TABULATE, PROC MEANS and PROC SQL.
• Developed, tested and maintained daily/monthly/quarterly report packages illustrating progress towards the strategic objectives.
• Documented policies and Procedures required for supporting system enhancements.
• Developed various reports like summary reports, tabular reports, excel reports etc., as per business requirements and created.
• Experience in using SAS Enterprise Guide in both windows and Linux environment.
• Ability to work efficiently in both independent and team environments, worked with Project
• Used sorting, merging and transpose techniques on input datasets for Data Preparation and to get the required output.
• Responsible for the Unit Testing, Integration Testing, QA and implementation.

Environment: SAS Enterprise Guide, SAS DI Studios, SAS Macro,SAS/SQL, SAS/Graph,SQL, MS Excel, SAS VA, SAS Management Console

Confidential, Tampa Florida

Sr. Statistical Programmer

Responsibilities:

• Interacted with business users, business analysts and translated business requirements into technical
• Leveraged industry expertise in providing topnotch SAS Programming and analysis support for phase III clinical trials
• Served as primary SAS programmer and collaborate with statistician in analyzing initial data sets and generating tables, listings and figures (TLFs) for clinical trials.
• Proactively performed and managed various duties such as data transformation and manipulation processes; ORACLE database management; creating and modifying new and existing SAS programs; and producing Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs);
• Oversee the clinical SAS programming and analysis functions and support for the entire clinical studies across multiple protocols for the submissions such as CSR and Safety.
• Play a key role in developing, debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings in accordance with departmental standards.
• Perform extensive QC (Quality Check) and analysis in reviewing other team members work as well as render primary support and assistance in data validation and data cleaning in all phases of Clinical studies
• Facilitate the modification and development of existing SAS programs as well as accountable for the creation of new programs using SAS Macros
• Work collaboratively with statisticians and clinical data managers in analyzing the Clinical Trials and generating Reports
• Generate analysis datasets based on the Data Definition Tables (DDT) and in accordance to the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.
• Utilize Proc CDISC for verifying compliance of datasets with CDISC standards and electronic submissions
• Experience in working on multiple protocols and/or drug compounds at a time

Environment: SAS UNIX, SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc. Oracle Clinical Database

Confidential, TX

Clinical SAS Programmer

Responsibilities:

• Oversee the clinical SAS programming and analysis functions and support for the entire clinical studies across multiple protocols for the submissions such as CSR and Safety
• Demonstrate proficiency in coordinating wide range of professional functions such as generating tables, listings, QC checking, and validating all outputs for Oncology clinical trials; developing reports for Safety and efficacy as per study requirements; debugging SAS compiling errors and identifying issues; producing reports or analysis data sets; and SAS data sets and other database management
• Play a key role in developing, debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings in accordance with departmental standards
• Responsible for providing SAS programming and analysis support for Phase I and Phase 2 clinical drug trial.
• Developed SAS programs to validate programs written by other SAS programmers.
• Being part of ISS team worked closely with the rest of the team in analyzing multiphase trial data and generated integrated summary of safety data sets, per SAP.
• Created validation and derivation procedures as needed in CDMS.
• Wrote programs to generate data discrepancy reports using edit check specifications provided by study data analyst.
• Generating the demographic tables, adverse events and serious adverse events reports.
• Used SAS/ACCESS to extract data from oracle and other relational database for analysis. Creating datasets from flat files excel worksheet.
• Prepared data for FDA submission as per CDISC submission standards and guidelines. I was involved in creating annotated case report form using CDISC-SDTM mapping.
• Worked extensively in FDA submission, with good knowledge of 21 CFR parts 11.
• Moved data sets across platforms (from PC & Mainframe to UNIX & Vice Versa).
• Reviewing of the protocol, Sop and CRF under the guidance of the bio-statistician and science group.
• QC program generated by the other developer for safety analysis.
• Imported and exported data from other data sources such as Excel.
• Involved in Statistical aspects of Clinical Trials, experimental design, data analysis, summarizing and reporting.
• Involved in validating and QC of the efficacy and safety tables.
• Review and integration of data obtained from electronic data capture and extracted data from oracle clinical.
• Effectively involved in the management of large data set and programming the data set.
• Modified existing SAS programs and created new programs for better performance and ease of use. And programs have been standardized using SAS macros.

Environment: SAS UNIX, SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc. Oracle Clinical Database

Confidential, PA

Clinical SAS Programmer

Responsibilities:

• Providing SAS programming and Analysis support for early development group, phase 1 oncology clinical drug trial.
• Responsible for developing new SAS programs and modifying existing programs and creating new listings and graphs.
• Participated with early development of the cancer drug in producing the tables and graphs.
• Generated tables and listing for demographic and adverse events for all grades.
• Generated death and reason for discontinuation tables and helped in the analysis of the output of the drug with the help of the bio-statisticians.
• Reviewing of the protocol, Sop and CRF under the guidance of the bio-statisticians and science group.
• QC program generated by the other developer for safety analysis.
• Imported and exported data from other data sources such as Excel.
• Involved in Statistical aspects of Clinical Trials, experimental design, data analysis, summarizing and reporting.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated Clinical / Statistical reports.
• Created and validated most of the SDTM datasets from raw dataset as per CDISC standards by using e-CRF.
• Created and validated most of the ADaM datasets from the SDTMs as per specification guidelines.
• Developed specifications for SDTM datasets according to CDISC implementation guide.
• Developed specifications for ADaM datasets as per SAP. Typically, like ADSL, ADLB, ADVS, ADPFS and ADEF etc.
• Involved in creating data-cut macros to apply data-cut to the raw data for ongoing studies.
• Map source raw data from EDC system like Oracle clinical and created SDTM datasets using industry standard CDISC implementation guidelines.
• Data cleaning to remove incorrect data entered by using edit check programs before data analysis.
• Created macros to retrieve the data from database. Involved in data cleaning by using various edit check techniques.
• Developed and validated CDISC complaint datasets. Handled huge datasets.
• Developed programs from the scratch and modified / updated existing programs.
• Designs specific data presentations including creative summary tables, graphs and patient listings.
• Modified standard macros as per study specification.
• Developed data and programming specifications jointly with other programmers.

Environment: SAS UNIX, SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc. Oracle Clinical Database

Confidential, IL

Clinical SAS Programmer

Responsibilities:

• Involved in generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Created designated Tables, Figures, and Listings according to Statistical Analysis Plan (SAP)
• Integrated data from multiple studies for ISS and ISE.
• Developed routine SAS Macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Experience creating ADaM datasets.
• Wrote, modified, and maintained programs which produce TLGs as well as complex safety and/or efficacy datasets, tables, and listings
• Developed and documented programs to create analysis datasets (ADaM) summarizing key clinical trial data
• Performed validation programming to ensure accuracy of TFLs and compliance with SAP and FDA regulatory requirements.
• Involved in creation of Therapeutic specific SDTM (TU, TR and RS - oncology) and ADaM (ADTU, ADTR - oncology) data sets.
• Generated tables and listings for - Adverse Events, Vital signs, clinical laboratory evaluations, disposition of subjects, concomitant medications and protocol violations.
• Reviewed Mapping document as well as analysis dataset specifications
• Reviewed define.pdf and DDH (data derivation and handling)
• Supported PSUR, DMC as well as Interim analysis
• Participated in the development of a library of SAS macros for use across multiple projects and in biostatisticians and other programmers in their implementation
• Handled Dropouts and Missing Data by using traditional approach of generating Last-Observation- Carried-Forward (LOCF) data on Visit-wise data.
• Planned, organized and handled multiple clinical projects and prioritized tasks
• Consulted (as needed) in the design and development of clinical trials, protocols and case report forms Assisted team to ensure timelines for the study and/or project are met
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/Macro facility.
• Maintained and updated existing utilities as per project requirements.
• Used department macros for report generation.
• Created designated tables for publication purpose.
• Performed quality controls (QC) on SAS programs.
• Maintained and updated existing utilities as per project requirements.

Environment: SAS UNIX, SAS/BASE, SAS/MACRO, SAS /GRAPH, SAS /STAT, SASA/SQL, SAS/ODS, Proc Report, Proc Tabulate, Proc Gplot, etc. Oracle Clinical Database

Confidential

SAS Programmer /Analyst

Responsibilities:

• Validated datasets as required by the client to find the missing data and imported toSAS Environment.
• Developed SAS programs for converting clinical data into SAS datasets using SQL Pass through facility and Libname facility.
• Worked with multi-disciplinary team which had SAS developer, clinical data coordinator, clinical research coordinator for reviewing the protocol and developing SAS datasets
• Created flat-files and sub-sets of SAS datasets.
• Responsible for the development and maintenance of SAS data and statistical analysis programs to support drug development projects.
• Designed new datasets with the modified values in tables using SAS statements, procedure and SAS functions.
• Wrote code using SAS/BASE and SAS/MACROS to extract data from ORACLE and MS ACCESS databases.
• Combined and Modified SAS datasets for statistical analysis using SAS data step and procedures including PROC SQL.
• Produced quality customized reports using PROC REPORT, PROC TABULATE and SAS/ODS.
• Provided descriptive analysis using PROC MEANS, PROC FREQ, PROC SORT and PROC UNIVARIATE.
• Developed and maintained standardized SAS Programs and MACROS to automate the production of standardized outputs.
• Developed Macros to create tables, graphs and listings for routine reports.
• Provided custom data listings, tables and figures for inclusion in Clinical Study Report (CSR) documentation.
• Performed statistical analyses using PROC GLM and PROC MIXED following the instructions in Statistical Analysis Plan.
• Created and Archived SAS Codes and Reports.
• Assisted statistician in preparing Statistical Analysis Plan (SAP).

Environment: SAS/BASE, SAS/ STAT, SAS/ODS, ORACLE, MS Access