SUMMARY

• Certified SAS programmer with 7 years of Experience in pharmaceutical industry.
• Involved in all four phases of clinical trials and supported in various therapeutic areas like Endocrinology, Hematology, Virology and Epidemiology.
• Extensively used SAS procedures and functions to produce Tables, Listings, Graphs (TLG) and derived datasets that summarize results of clinical trials.
• Experience in using various SAS modules such as SAS/BASE, SAS/STAT, SAS/ODS, SAS/GRAPH and SAS/ACCESS.
• Hands on knowledge in various SAS procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC SORT, PROC TRANSPOSE, PROC UNIVARIATE, PROC ANOVA, PROC SUMMARY etc.
• Extensively used SAS/ODS procedures to develop various HTML, RTF and PDF reports.
• Extensive experience in developing and executing of SAS programs to analyze and generate analysis data sets (EDS), validations for integrated summaries of safety and efficacy (ISS/ISE).
• Developed SAS programs to check data quality in analysis data sets and automated scripts to check data stability.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines and hands on experience in implementing CDISC/SDTM standards and Define.xml.
• Knowledge of CRF - Annotation with respect to various database designs.
• Thorough knowledge in Phase I, Phase II, Phase III and Phase IV of clinical trials and single blinded 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).
• Reviewed Case Report Forms (CRFs) and Statistical Analysis Plans (SAPs) under the guidance of biostatisticians.
• Responsible for writing and debugging statistical programming and documented programming procedures.
• Knowledge of basic UNIX commands and experience in both UNIX and windows versions of SAS.
• Highly self-motivated and goal-oriented professional with rational problem solving and sound decision making capabilities.
• Excellent team player, ability to work independently with least supervision.

TECHNICAL SKILLS:

SAS Tools: Base SAS, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/GRAPH, SAS Enterprise Guide.

Operating Systems: Windows, UNIX

Databases: Oracle, MS Access, MS Excel.

PROFESSIONAL EXPERIENCES:

Confidential, CA

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, NC

SAS programmer

Responsibilities:

• Imported data and created SAS datasets from flat files of various formats, including CSV, XPT etc.
• Created SAS datasets using BASE SAS and SAS/SQL using SQL Pass-through facility from ORACLE tables.
• Cleaned and analyzed the data sets using DATA NULL, PROC FREQ, PROC MEANS and PROC UNIVARIATE.
• Developed programs for analyzing datasets, summarizing key clinical trial data.
• Extensively worked on SDTM and ADaM datasets under CDISC guidelines.
• Generated Tables, Listings and Graphs in accordance with approved statistical analysis plan (SAP).
• Used SAS/STAT procedures such as Proc Univariate, Proc Means for data validation and Proc t-test, Proc F-test for statistical analysis.
• Extensively used ODS functionality of SAS to created EXCEL, RTF, PDF reports.
• Performed validation of deliverables through independent programming.
• Supported multiple clinical trials at different phases of FDA submissions.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for data cleaning, validation, and analysis and report generation.
• Successfully handled multi-projects/tasks at a time.
• Involved in extensive communication with manager, data management and statisticians.

Confidential, CA

Clinical SAS programmer

Responsibilities:

• Developed new or modified SAS programs to load data from the source and create study specific datasets.
• Reviewed and provided inputs to CRF’s statistical analysis plans and analysis datasets (ADS).
• Developed SDTM data mapping and created SDTM domains such as AE, LB, DM, SE, EG, EX, IE etc and their SUPPQUAL datasets.
• Generated summary reports, listing and graphs for regulatory submissions using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GCHART.
• Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Developed macros for Data Cleaning, Validation, Analysis and Report generation.
• Extensively used SAS Macro options such as MPRINT, MLOGIC and SYMBOLGEN to test and debug existing macro programs.
• Developed case report forms (CRF), data validations, and data quality plans.
• Used the CDISC-SDTM to CRT-DDS transformation to transform SDTM domains into a define.xml file.
• Wrote programs in SAS to generate reports, creating RTF, HTML listings, tables and reports using ODS.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.

Environment: SASBASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCES

Confidential, MI

Clinical SAS Programmer

Responsibilities:

• Involved in the analysis of Phase III of clinical trials and handled data validations and populating analysis data sets.
• Create and extract 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.
• DevelopedSASprograms usingSAS/BASE andSAS/SQL for preparing analysis and reports from databases.
• Writing analysis plans including specifications for tables, listings and Figures. Taking raw data and creating datasets.
• 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 andSAS/Macros to extract clean and validate data from oracle tables.

Environment: SAS 9.0, Base/ SAS, SAS/ Access, SAS/ Macro, SAS/ Connect, SAS/STAT, Windows 2000

Confidential

SAS Programmer/Analyst

Responsibilities:

• Worked with different clinical trials data like Demographics, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory and Physical Examination.
• Generated Tables, Listings and Graphs using various procedures like PROC FREQ, Proc Report, Proc Tabulate, Proc Univariate, Proc Plot, and Proc Gplot.
• Performed Data Validation and Data Cleaning on Clinical data using procedures like Proc Freq, Proc Means, and Proc Univariate.
• Used SAS Macros extensively in the creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Wrote SQL Queries to check data for different conditions like duplicate values and missing values.
• Integrated with Clinical, Regulatory and Data Management colleagues to coordinate collection and reporting of clinical studies.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Generated graphs using SAS/GRAPH.

Environment: SAS/BASE, SAS/MACRO, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT.