SUMMARY

• Certified SAS Programmer with more than seven years of experience in SAS programming for data management, reporting and analysis of clinical trials.
• Supported various contract research organizations (CRO) and pharmaceutical and health care companies in regulatory submissions.
• Experience in various therapeutic areas such as Oncology, GI, respiratory, CNS, Cardiovascular and Inflammatory.
• Excellent experience in using SAS/ACCESS, PROC SQL and PROC IMPORT to extract and import external data into SAS libraries.
• Hands on experience in SAS/Base procedures for data manipulation such as PROC TRANSPOSE, PROC SORT, PROC APPEND and PROC SQL.
• Expertise in using SAS procedures such as PROC FREQ, PROC UNIVARIATE and PROC MEANS for data validations.
• Extensive knowledge on CDISC standards and advanced SAS programming skills in generating SDTM/ADAM datasets.
• Extensive experience in generating reports employing various SAS data steps and procedures such as DATA NULL, PROC SUMMARY, PROC TABULATE, and PROC REPORT.
• Through understanding of clinical trials methodology, FDA Guidelines, ISS and ISE for NDA submission
• Extensively used SAS/BASE, SAS/GRAPH procedures for creating Tables, Listings, Graphs (TLG) and analysis data sets for both safety and efficacy.
• Hands on knowledge on SAS/STAT procedures such as T - test, F-test, REG, GLM and using SAS/MACROS for generating statistical summary tables and reports.
• Solid knowledge of CRT dataset creation, CDISC, SDTM 3.1.1, SDTM3.1.2 and MedDra Version 11 for regulatory submissions.
• Experience in creating and validating define.xml file and implementing SAS/ODS procedures to create RTF, HTML and PDF files.
• Involved in reviewing essential trial documents such as protocol, CRF, Data Management Plan (DMP), Statistical Analysis Plan (SAP) for submission.
• Excellent team player with an ability to work closely with programmers, developers, statisticians and data managers.
• Highly self-motivated with an ability to work independently in distributed work environments with minimal supervision.

TECHNICAL SKILLS

SAS Tools: SAS V9.1.3, SAS V9.2, Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS SAS/Connect, SAS/Share SAS Enterprise Guide, SAS JMP, SAS Enterprise Miner, SAS Text Miner, SAS Sentiment Analysis Studio, SAS Content Categorization

Operating Systems: Unix, Linux, Windows 7, Windows XPDatabases Oracle, Teradata, MS SQL SERVER & MS ACCESS

Microsoft tools: MS office toolset (Word, Excel, Power point, Access), VBA

Core Competencies: Statistical Programming, Data Analysis, Reports Development, Modeling, Clinical Trials

Business Intelligence Tools: Tableau, IBM SPSS Modeler, IBM Cognos, Microstrategy

PROFESSIONAL EXPERIENCE

Confidential, San Francisco, CA

Clinical SAS Programmer

Responsibilities:

• Involved in writing, analyzing, and presenting of clinical trial reports for Phase I and Phase II of clinical trials.
• Accessed SAS clinical tables using SAS Access facility to connect to Abbott’s oracle database.
• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.
• Used BASE SAS to perform sorting, indexing, merging of the datasets.
• Worked on data analysis, statistical analysis and generated Reports, Listings and Graphs using BASE SAS and SAS procedures such as PROC SUMMARY, PROC TABULATE, PROC FREQ, PROC SG-PLOT, PROC PLOT and ODS procedure.
• Transformed existing raw data into standardized CDISC SDTM/ADaM domain datasets using various SAS procedures.
• Extensively used SAS/MACRO facility to provide reusable programs that can be conveniently used time-to-time and created tables, graphs and listing reports.
• Prepared/reviewed protocol documents, case report forms, annotated CRF, and statistical analysis plans for clinical trials.
• Worked with different CDISC data models such as SDTM, ADaM and Define.xml.
• Provided SAS programming support to Statisticians, Data Managers, and the Medical Writers to develop reports.
• Generate Ad hoc statistical analysis Reports/Listings as required.
• Generated Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS).
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Established and maintained sound working relationship and effective communication.
• Assisted biostatisticians and the data management group for requirements gathering and report finalization.

Environment: SASBASE, SAS/STAT, SAS/GRAPH, SAS/ACCES, Oracle Clinical, Windows XP

Confidential, Elkridge, MD

SAS Programmer

Responsibilities:

• Supported various clinical trials studies by providing SAS programming support for data processing, data analysis, statistical analysis and report generation.
• Converted raw data sets, excel files into SAS data sets using SAS Enterprise Guide and SAS/BASE
• Used SAS/Access facility and SAS SQL Pass Through facility to access or load data files into Oracle
• Extensively used sorting and merging techniques to create analysis data sets and processed data to meet CDISC standards
• Developed and executed edit check programs for data validation
• Performed data analysis, statistical analysis, generated reports, listings and graphs using SAS tools within SAS/BASE and SAS/GRAPH
• Developed reports using SAS reporting procedures such as PROC REPORT, PROC SUMAMRY and PROC TABULATE
• Used CDISC-SDTM to CRT-DDS transformation to transform SDTM domains into a define.xml file
• Developed routine SAS MACROS to create tables, graphs and listings (T/F/L) for inclusion in clinical study reports and regulatory submissions
• Developed safety listings, tables and plasma concentration graphs for clinical study team and bio-statistical team review
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS
• Reviewed and provided feedback for Data Integrity Plans
• Attended project team meetings and worked closely with Bio-Statisticians, Data Managers, and Clinical Research Managers

Environment: SAS 9.1.3, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Graph, SAS/STAT, UNIX and Windows

Confidential, Hawthorne, NY

SAS Programmer

Responsibilities:

• Reviewed and acquired knowledge about documents related to clinical trials like Clinical Protocol, SAP, Clinical Study Report and a CRF (Annotated CRF).
• Developed, modified and implemented SAS programming work according to SAP.
• Worked with Clinical Data Management team for creating annotated CRF.
• Used DATA steps to derive analysis datasets from raw data using defined features in SAP and CRF.
• Created new analysis datasets from raw datasets for clinical trials
• 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 SAS MACROS for effective and efficient outputs for clinical trials.
• Created study specific SAS MACROS for better performance.
• Developed mock-up tables referring CRF, SAP
• Participated in periodic meetings with the project leaders, subject matter experts and provided reports detailing the progress.

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Graph, SAS/STAT, Oracle, UNIX and Windows

Confidential, New London, CT

SAS Programmer

Responsibilities:

• Involved in the analysis of Phase III clinical trial and handled data validations and populating analysis data sets.
• Created and extracted Oracle tables from SAS and within Oracle by using SAS/Access and PROC SQL.
• Extensively used data manipulation procedures such as merge, append, set to create analysis data sets
• Reviewed SAPs, protocols and generated tables, listings and graphs using PROC PRINT, PROC REPORT, PROC TABULATE and PROC GPLOT
• Generated summary reports and descriptive statistics using SAS/Base and SAS/STAT Procedures.
• Created and applied user-defined formats to specific variables in SAS data sets.
• Developed SAS programs using SAS/BASE and SAS/SQL for preparing analysis datasets and reports from databases
• Prepared analysis plans including specifications for tables, listings and Figures.
• Accessed External Excel files, stored and retrieved SAS data sets moving data through multi platforms.
• Used SAS data step functions, formats, statements and procedures like PROC FORMAT and to map the variables to the customer’s needs.
• Involved in writing code using BASE SAS and SAS/MACROS to extract clean and validate data from oracle tables

Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Graph, SAS/STAT and Windows

Confidential

SAS Programmer

Responsibilities:

• Performed various data management activities like pre-processing of data, writing SQL queries, edit check programming, and statistical analysis using Base SAS and various other tools -SAS/SQL, SAS/MACRO, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
• Developed SAS programs for extracting the Oracle Database into SAS datasets using SQL Pass through facility.
• Used Proc Import and Import Wizard to generate datasets from Excel sheets.
• Conducted analysis on the raw data to achieve the safety and efficacy objectives of the study using various SAS procedures such as FREQ, MEANS, UNIVARIATE, TTEST, CORR, REG etc.
• Developed and validated SAS programs following the information stated in Statistical Analysis Plan (SAP).
• Safety tables included Adverse Events (AE), Vital Signs, Laboratory Values, and Concomitant Medications etc.
• Involved in validating SAS programs developed by other programmers for the efficacy and safety tables.
• Created Tables and Listing for Safety as well as Efficacy analysis for the Study.
• Involved in generating the summary tables required in submission of ISS and ISE as per FDA regulation.
• Generated reports using PROC FREQ, MEANS, PRINT, TABLUATE and REPORT.
• Implemented edit checks utilizing SAS MACROS.
• Created CRT (Case Report Tabulation) for both standard and new domains.
• Contributed to the development of standard operating procedures (SOPs).

Environment: SAS/GRAPH, SAS/CONNECT, SAS/STAT, Excel, Access, Oracle