Clinical SAS Programmer

Surya

Ph# 909-***-****

**********@*****.***

Summary:

• Over Five years of experience in programming, analyzing and reporting in various Pharmaceutical, Biotech, and Healthcare using SAS on Windows and Unix environments.

• Knowledge of the drug development process with strong experience of analyzing and reporting in phase I, II, III and IV of clinical trial data.

• Working knowledge of data extraction from oracle clinical database and flat files as SAS views and datasets using PROC ACCESS, SQL pass-through facility and Oracle libname engine.

• Experience in data transformations & edit checks and commanding experience in analyzing Case Report Form (CRF) data.

• Experience in PK/PD analysis by performing parameters like, AUC max, Half-Life, cmax tmax, volume, Accumulation ratio, etc.

• Generated ad-hoc reports for post marketing pharmacovigilence analysis datasets and delivered data dumps for clinical data management before /after database lock.

• Experience in developing analysis plans including specs for tables, listing, graphs and Validation.

• Involved in validating and QC of efficacy and safety tables and also data conversions.

• Created transport file and Data Definition Document (DDD) reports for E-submission. Familiar with the clinical data reporting in CDISC SDTM 3.1.1 format

• Extensive experience in Clinical Data Management, data analysis, and to generate CRT /eCRT

• Accustomed to working in challenging environments under deadlines, excellent analytical, and problem solving skills.

Education:

• Bachelors of Technology, Jawaharlal Nehru Technological University, India

Technical Skills:

SAS Skills: SAS (BASE, ACCESS, MACROS, CONNECT, GRAPH).

Therapeutic Areas: Cardiology, Neuroscience

Languages: C, HTML, SQL

Databases: Oracle, MS SQL, MS Access.

Operating Systems: Windows, UNIX Environments

Professional Experience:

Bristol-Myers Squibb, Princeton, NJ May 2009- Present

SAS Programmer Consultant

Responsibilities:

Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.

• Used Dynamic Data Exchange (DDE) feature of SAS for importing and exporting of data from and into SAS and Excel.

• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII.

• Created complex and reusable Macros and extensively used existing macros.

• Developed SAS programs for data cleaning, validation.

• Generated ad-hoc reports for raw datasets using Print and Report procedures.

• Delivered data dumps for Clinical Data Management before database lock.

• Developed safety listings, tables and plasma concentration graphs for clinical study team and bio-statistical team review.

• 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: SAS 8.0, SAS/MACROS, SAS/SQL, SAS/Graph, SQL, SAS/STAT, MS Office, Oracle, and Windows NT.

Acorda Therapeutics, Hawthorne, NY Feb 2007-Mar 2008

SAS Programmer Consultant

Acorda is a Contract Research Organization (CRO) whose mission offers a full range of clinical research services for Phase I-IV for different pharmaceutical companies.

Responsibilities:

• Review and acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).

• Worked with Clinical Data Management team for creating annotated 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 macros for effective and efficient outputs for clinical trials. Created study specific macros for better performance.

• Hands on Experience in developing mock-up tables referring CRF, SAP

• Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the work progress and queries regarding Project.

Environment: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/WINDOWS

Endpoint Research, Burlington, MA Jan 2007-Dec 2007

SAS Programmer Consultant

Responsibilities:

• Developed SAS programs to listings/graphs to create study specific datasets, which were used as source datasets for report generation.

• Developed analysis plans including specs for tables, listing, graphs and validation plan

• Worked on pre-specified statistical tables, figures, and reports for publication.

• Developed listings, tables and graphs for efficacy and safety of clinical studies.

• Created reusable Macros and developed SAS Programs for Data Cleaning, Validation and Analysis and Report generation.

• Developed procedures to standardize analysis programs, including a macro library.

Environment: SAS/BASE, SAS/MACRO, SAS/CONECT, SAS/STAT, Windows NT, MS Office, MS-Excel

APOLLO HOSPITALS, Hyderabad, INDIA Oct 2005-Nov 2006

SAS Programmer

Responsibilities

• Designed reports for key health care modules like administration IP billing OP billing and pharmacy as per the requirements of the higher authorities

• Created reports for finding out the load balance of the patients for particular time intervals for analysis of business

• Converted MS SQL server data tables into SAS data files using SAS SQL and uploaded SAS data files into MS SQL Server tables using Proc Dbload

• Imported the data into SAS from Excel Spreadsheet, and various delimited files using Proc Import to generate reports as per the directions of the higher management

• Generated reports using Proc Tabulate, Proc Report, Data Null, SAS arrays, Proc SQL, and SAS Macros

• Extracted data from MS SQL Server using SQL pass through facility and generated ad-hoc reports

• Tested and debugged SAS programs against the test data

• Processed the data in SAS for the given requirement using SAS programming concepts

• Imported and Exported data files to and from SAS using Proc Import and Proc Export from Excel and various delimited text based data files such as .TXT (tab delimited) and .CSV (comma delimited) files into SAS datasets for analysis

• Used statistical analysis procedures in the generation of reports periodically for analyzing the business using SAS STAT procedures such as Regression Univariate, Correlation, and ANOVA

• Utilized procedures such as Proc Access, Proc SQL and Proc Dbload in SAS/ACCESS to retrieve the data into SAS from MS SQL server database

• In Data Transformation and Manipulation process, extensively used procedures like SQL, Transpose, Tabulate, Copy, Cport, Cimport, Sort, Datasets, Dbload etc

Environment: SAS/Base, SAS/STAT, SAS/GRAPH, SAS ODS.SAS/MACROS, SAS/ACCESS, MS-Office

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