Clinical sas programmer resume in WOODBRIDGE, NJ, 07095

Clinical sas programmer

Posted by:	Name is not set.
Posted date:	10/5/2009
Contact Info:	******** ***** *******... Show Contact Info (premium) Send Message (free)
Country:	United States
State:	New Jersey
City:	WOODBRIDGE
ZIP:	07095
Email:	fq1l52@r.postjobfree.com

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SUNDARESAN MURUGESAN fq1l52@r.postjobfree.com
Phone: 917-226-****
__________________________________________________________________________

Professional Summary:
• SAS certified Programmer with over 6 Years of industry experience in using SAS for Data Management and reporting in the Healthcare and Pharmaceutical fields.
• Involved in Three Phases (I-III) of the Clinical Trials in different Therapeutics areas - Cardio-Vascular, and Oncology trials.
• Experience in preparation of SAS datasets, Tables, Listings, Graphs, Reports, Output Delivery System (ODS) and Summaries according to requirements, Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP).
• Strong experience in Base SAS, SAS/MACROS, SAS/ACCESS, SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS/ODS and SAS/SQL in Windows and UNIX environments.
• Knowledge of Clinical Terminology and regulatory Guidelines.
• Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.
• Experience with transforming data in various formats (excel, CSV, ASCII) into SAS datasets.
• Experience working with Pharmacokinetics and Pharmacodynamics property of the drug.
• Developed programs in SAS Base for converting the Oracle Data for a phase I - III study into SAS datasets using SQL Pass through facility and Libname facility.
• Experience in Data Manipulation procedures such as SAS Formats/Informats, Merge, Proc Append, Proc Datasets, Proc Sort and Proc Transpose.
• Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Experience in Data mapping from none CDISC SDTM to SDTM and data mapping from SDTM to ADaM standards.
• Experience in creating CDISC Domain Specifications and Data Definition (Define.xml) Documents.
• Experience in validating CDISC SDTM Domains using Proc CDISC Procedure.
• Experience in validating SAS Datasets, Tables, Listing and Figures using Proc Compare Procedure.
• Proficient in understanding of Study Protocols, SAP (Statistical analysis plan), and CRF’s.
• Having excellent command in producing reports employing various SAS procedures like Proc Print, Proc Report, Proc Tabulate, Proc Mean, Proc Freq,Proc Univariate, Proc Transpose, and Data _NULL_ .
• Strong experience using SAS/GRAPH to produce Graphs by employing SAS procedures such as Proc Gplot and Proc Gchart.
• Exceptional ability in problem solving, data analysis, complex reports generation with macro and data transfer between different environments.
• Expertise in transforming data imported from disparate data sources into analysis data structures, using SAS functions, options, ODS, array processing, macro facility, and storing and managing data in SAS data files.
• Experienced in producing RTF, PDF, HTML and MS Excel formatted files using SAS ODS facility.
• Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• 100% Project completion on time while meeting strict timelines and budget requirements.
• Quick learner and excellent team player, ability to meet deadlines and work under pressure.

Professional Certification:
SAS Certified Base Programmer for SAS9
SAS Certified Advanced Programmer for SAS9

Education:
Master of Science in Bioinformatics
New York University, USA.

Bachelor of Science in Biotechnology
Anna University, INDIA.

Technical skills:
Statistical Packages:
SAS Tools: SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/ODS,
SAS/REPORTS, SAS/ACCESS, SAS/STAT.
SAS Procs: Print, Means, Univariate, Correlation, Regression, SQL, Report,
Freq, Sort, Summary, Format, Import, Export, Transpose,
Compare, Gplot and Gchart.
Database:
SQL Server, Oracle and MS Access
Development Tools:
MS Office.
Operating Systems:
Windows NT Server, Windows XP, UNIX, Linux (Red Hat), Mac OS X.

Professional Experience:

Quartesian CRO: Princeton, NJ Apr’ 08 to Sep’09
Role: Sr. Statistical Programmer
The Quartesian is one of the most innovative, productive, and respected scientific research analysis organizations in health care. Primary responsibilities include the production of CDISC SDTM Compliant datasets and specifications, summary tables, figures, listings and statistical analyses for efficacy and safety as well as providing edit checks, data review listings, & validation.

Responsibilities:

• Worked extensively to generate SAS data sets, statistical reports, monthly reports, listings, safety reports for cross-functional teams for Phase I to II of Cardio-Vascular Clinical Trial Data.
• Created CDISC SDTM Domains Specification and Data Definition (Define.xml) Documents.
• Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard, data mapping from SDTM to ADaM Domains and review CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.
• Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs.
• Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Validated CDISC SDTM Domains using Proc CDISC Procedure.
• Created SDTM datasets for safety and efficacy domains and Created SAS macros for SDTM mapping.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS,PROC FREQ,PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Created SAS Customized Reports using the Data _Null_ technique.
• SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analyses and the SAS REPORT procedure is generally used to display results.
• Used SAS ODS to produce HTML, PDF and RTF format files.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for multiple trials.

Environment: SAS/BASE, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/MACRO, Windows NT.

Access Pharmaceuticals, Inc. TX Jan'07 - Feb'08 Role: Clinical SAS programmer

Access pharmaceuticals are a biopharmaceutical company dedicated to research in oncology, with primary goal of developing new treatments and supportive care for cancer patients. The project focused on analyzing the data from a comparative study of investigational adjuvant therapy with an established adjuvant therapy in preventing the recurrence of cancer in surgically treated stage III colon cancer patients. Access is developing Phenyl butyrate (PB) which is also in Phase 2 clinical trials. PB is a pleotropic agent which current evidence suggests acts as both an HDAC inhibitor and a differentiating agent. HDAC inhibitors have potent anticancer activity by suppressing specific enzymes found in cancer cells.

Responsibilities:
• Involved in managing randomized phase II and III clinical trials data.
• Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
• 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.
• Prepared new Datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Generated Tables, Graphs and Listings for inclusion in Clinical study reports and regulatory submission; Participated in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Modified macros for report generation using SAS Macros as per the statistician’s requirements.
• Developed efficacy and safety tables including Adverse Events table, Laboratory Shift table and Concomitant Medication tables.
• Generated summary reports, listing and graphs using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, GPLOT and GHART.
• Wrote programs in SAS to generate reports, creating RTF, HTML listings, tables and reports using SAS/ ODS for Ad-Hoc report generation.
• 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/ACCESS, UNIX.

MGI Pharma, Inc., Bloomington, MN May'06 - Dec’06
Role: SAS Programmer

MGI Pharma, Inc. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. This project involves the creation of SAS data sets using the raw clinical data for analyzing the Pharmacokinetics, Pharmacodynamics property of the drug, safety and efficacy reports.

Responsibilities:
• Created, derived and merged and pooled datasets, listings and summary tables for Phase-I and Phase II of clinical trials.
• The accuracy and integrity of clinical data were verified by performing validation checks written in SAS and checked for data related errors, outliers, and missing values.
• Involved in analyzing Pharmacokinetics and Pharmacodynamics Property of the drug using PK/PD Parameters.
• Macros were written at various instances for automating listings and graphing of clinical data for analysis.
• Provided computer-programming support to Data Management and Biostatistics.
• Programmed edit check procedures to ensure validity of data collected internally.
• Involved in validating and QC of the efficacy and safety tables.
• Created SAS reports using the Data _Null_ technique and the PROC Report for the NDA submission as per the FDA regulations and company standards.

Environment: SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, WINDOWS.

Ranbaxy Pharmaceuticals, Bombay, INDIA Feb’04– Mar'06
Role: SAS Programmer

Ranbaxy Pharmaceuticals is a major Pharmaceutical and bulk drug industry based in Bombay, is leader in manufacturing drugs. As a SAS programmer, performed relevant statistical analysis of administrative and automated claims databases, surveys and economic data captured during clinical trials. The project I participated was the Phase I and II clinical trial of the drug.

Responsibilities:
• Worked in Phase I & II of clinical trials for studies in the Cardio-Vascular therapeutic area.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning with data steps using DLM, DSM, and COMMA9. TRUNCOVER, MISSOVER etc.
• Performed data validation on the data sets and deleted repeated values using conditional data steps such as @@, if-then statements.
• Designed statistical tables, graphs, and data listings.
• Created Data transformation and Data Loading (ETL) scripts for Data Warehouse.
• Developed SAS macros for data cleaning and reporting and to support routing processing.
• Performed Data Analysis on the data sets using PROC ANNOVA, PROC MEAN, PROC UNIVARIATE, PROC FREQ and PROC TRANSPOSE.
• Developed reports using PROC REPORT, PROC TABULATE and DATA _NULL_.
• Generated output files in text format, HTML & PDF format using SAS ODS.

Environment: SAS BASE, SAS/STAT, SAS/SQL, SAS Macro, SAS/ACCESS, and UNIX.

Veeda Clinical Research, India Mar’03- Jan’04
Role: SAS Trainee/Programmer

Veeda Clinical research is dedicated in Oncology clinical research and serves internationally for the pharmaceutical and biotech industries with offices in the US, Europe and India.

Responsibilities:
• Involved in the analysis of Phase I and Phase II clinical data.
• Cleaning of data using data step and SAS base Procedures.
• Assigned formats and labels to the variables in analysis data sets.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC PRINT, PROC REPORT, PROC TABULATE and PROC GPLOT.
• Generated summary reports and descriptive statistics.
• 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 and reports from databases.
• Responsible for data validation and corrections – uploading / downloading data.
• Create and extract Oracle tables from SAS and within Oracle by using SAS/Access, SAS/SQL.
• 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 and SAS/Macros to extract clean and validate data from oracle tables.

Environment: SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/ACCESS, ORACLE, WINDOWS.

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