CAREER OBJECTIVE

To seek an exciting and challenging position utilizing my knowledge, skills and experience in the various field of data analyses using SAS technologies.

SUMMARY

• 5 years of experience of SAS programming, Statistical Analyst in Pharmaceutical research and development group of CRO for data analysis, coding and creating CSR.
• Expertise in analysis & reporting using SAS/BASE, SAS/STAT SAS/Macros, SAS/Reports, SAS/Graphs, SAS/ACCESS, SAS/CONNECT, SAS/SQL.
• Knowledge of 21 CFR-PART 11, 21 CFR-PART 312.33 federal regulations, E3, E9, E6 (GCP) guidance for FDA submission.
• Experienced with CDISC defined SDTM, ADaM, ODM, CRT data model standard for transforming and creating analysis dataset for generating TFL’s.
• Worked with Bio-statistician, Clinical Data Management Group (CDM), Project Manager, Medical Writers to provide SAS programming in designing CRF forms, data cleaning, data coding (free-text data coded with MedDRA & WHODRUG dictionary), data quality control, creating analysis data as per SAP.
• Experienced in SAS/ACCESS SQL Pass-Through facility, LIBNAME, PROC IMPORT/ EXPORT & SAS IMPORT/EXPORT Wizard, SAS Enterprise guide, ODM-XML, XML LIBNAME, PROC CDISC, SAS XML MAPPER, PROC CPORT, DBMS/Copy (non-proprietary to SAS data formats) for importing and exporting RDBMS- Non- RDBMS, Clinical data management, IVRS data.
• Experienced in producing ASCII text, HTML, RTF, PDF formatted reports using SAS/ODS.
• Expertise of generating report using SAS Functions and SAS procedures like, PROC REPORT, PROC TABULATE, PROC TRANSPOSE and customized report using extensive use of DATA_NULL programming.
• Experienced in descriptive and inferential statistical analysis for continuous and categorical clinical data using PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ, PROC TTEST, PROC LOGISTIC, PROC GLM, PROC NPAR1WAY, Kaplan-Meier Survival test using PROC LIFETEST.
• Experienced in generating common clinical trial graphs like scatter plot, line plot, bar chart, box chart, odds ratio plot, survival estimation plot using SAS/ GRAPH, PROC GPLOT PROC GCHART, PROC BOXPLOT, PROC UNIVARIATE, PROC LIFETEST.
• Strong interpersonal skills, ability to interact with people at all levels. Good communication, analytical and presentation skills.

Professional Certification

• Certified “SAS BASE PROGRAMMER FOR SAS@9 with 97 percentile”
• Certified training in MATLAB and signal processing toolbox

Technical Skills

Statistical software : SAS (Base SAS, SAS/SQL, SAS/MACRO, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/ODS)
SAS Procedures : PROC SQL, PROC REPORT, PROC TABULATE, PROC PRINT, PROC MEANS,  PROC FREQ, PROC UNIVARIATE, PROC SORT, PROC DATASETS, PROC 
CONTENTS, PROC TRANSPOSE, PROC COMPARE, PROC REG, PROC CORR, PROC ANOVA, PROCIMPORT, PROC EXPORT, PROC DBLOAD, AND PROC UNIVARIATE.
SAS Clinical Trial procedures : PROC CDISC, SAS XPORT Format, PROC LIFETEST.
Web Tools/technologies: HTML, XML, SAS/XML Mapper
Languages & Tools : SAS, MATLAB, C, SQL
Database : MS Access, Oracle10g
Operating Systems : Windows 98/2000/XP/Vista, UNIX, Open VMS
Office Application : MS-Office Suite, MS-Visio, MS Project.

PROFESSIONAL TECHNICAL EXPERIENCE

‘Programmer Analyst’- Confidential. Austin, TX (Apr 2009- Nov 2009)

Confidential is leading global contract research organization (CRO) providing discovery, development and post-approval services as well as compound partnering programs. I worked as programmer analyst in biostatistics group and involved in statistical programming of clinical trial data for different client through out the world.
Responsibilities :

• Involved in various clinical trial study for different client and tasks include reviewing protocol, annotated CRF, DST (dataset specification table of Oracle Clinical), DVM (data validation manual).
• Mapped raw data as per CDISC standard for SDTM and ADaM dataset.
• Generated DM listing as per RPS (Report Programming Specification) for different class of clinical trial data and delivered to DM group for edit-check and resolved discrepancy in data.
• Used DATA step programming, various PROC, Macros, SQL query for clinical SAS programming
• Used LOGCHECK for checking logic and resolved common programming error in SAS by scanning prohibited, conditional, warning and error keyword to reduce validation efforts.
• Validated listing and specification of other senior level programmer by working in group of team.
• On-time delivery of study specific deliverables to client as per client requirements and upon higher management request.
• Created and managed project related documents and folder and updated with latest version of program for consistency and reduce time while reporting.
• Programmed and validated various MACROS for regularity, reducing repetitive tasks and dynamic programming.
• Involved in SAP reviewing for TLF specification, suggested modification to biostatistician and clients for STAT programming of trial data.
• Validated TLF by working in group of team.
• Involved in reviewing import, extract, export agreement and modification for various vendors lab data through out the world.
• Generated SAS program (using DATA step, IMPORT, EXPORT, INFORMAT, FORMAT, and INPUT) for importing/exporting vendor’s lab data for statistical analysis and filling related documents once data successfully loaded into system.
• Created SAS XPORT format files for submission and transferring to different platform.

Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/SQL, MATLAB, SAS/ODS, SAS/Report, Oracle Clinical, Open VMS (DCL language), PC/SAS.

‘Statistical Programmer’- Confidential. Dallas, TX (Jan 2008- Jan 2009)

Project Description: 
Confidential is an emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing the products through clinical development. I Worked with Biostatisticians, project manager and data management group for Phase II oncology study for advance or recurrent squamous cell carcinoma of the cervix.

Responsibilities :

• Categorized clinical trial data as per CDISC into intervention class, event class, finding class, demographic class.
• Involved in activities such as, tracking, cleaning, querying and updating CRF from query resolution by site management.
• SAS Import procedure/ Import wizard for non-RDMS (Excel, Access) data importing and SQL-pass through facility for importing data from RDBMS.
• As per SAP and CP created derived variable like response rate, duration of response, time to treatment failure, survival for specification of analysis datasets.
• Worked with CDM for transformed data using DATA step programming, PROC Transpose, Windowing, merging free-text data with COSTART medical dictionary for analysis datasets like evaluable population & safety population, change from baseline, time-to event analysis.
• Oncological assessment, Oncology history (prior radiation and prior surgery to treat disease), Subject demographics, vital signs, lab parameters, BSA summarized using SAS procedures like PROC UNIVARIATE, PROC FREQS.
• Prepared Efficacy analysis with tumor response (CR or PR) and survival by customized DATA_NULL programming, PROC TABULATE, PROC REPORT, FORMCHAR option for ASCII text for FDA submission.
• Summarized table as per mock TLG for extent of exposure, adverse event, haematology and serum toxicities, non-investigational medication, and vital sign for summary analysis.
• Developed TLG (table, listing, graph) and report of patient’s data with descriptive and inferential statistics for continuous/categorical variables programmed by extensively using PROC FREQ, PROC UNIVARIATE, PROC MEANS, PROC LOGISTIC.
• Created Kaplan-Meier survival estimation table & plot using analysis dataset by programming, interleaving, match-merging, SAS/MACRO, PROC LIFETEST.
• Case report form Tabulation (CRT) using PROC REPORT as per CDISC SDTM standard.
• Created SAS XPORT format file as per eCTD guideline using SAS/Macro, PROC COPY, PROC CPORT
• 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.
• Formatted HTML, PDF and RTF reports, using SAS/ODS system.

Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/SQL, MATLAB, SAS/ODS, SAS/Report, SAS/XML Mapper Oracle9i, Window NT/2000, Excel/Access 2000.

‘Clinical SAS Programmer’- Confidential, UT (Aug 2006- Dec 2007)

Project Description:
Confidential is a leading life science company. The strategy of this company is to develop novel health care products in areas of critical need and to address some of the most pervasive diseases of our time. Duties involved Generated safety tables and involved in analysing data and creating reports as per E3, E9, E6 (GCP) guidance.
Responsibilities:

• Reviewed clinical protocol and statistical analysis plan (SAP), tables, listing, specification and provided feedback to the statistician
• Derived patient’s data, baseline observation, study day, windowing data, and extracted data from IVRS & EDC system for randomized schema and transposing for analysis dataset.
• Data extraction from Oracle clinical using SQL pass-through facility and LIBNAME.
• Performed many to many comparisons/joins using PROC SQL, one-to-one merging by MERGE-BY statement for adverse event and concomitant analysis data sets.
• Created summary table’s as per “table shell” for Patient disposition, Demographics/baseline characteristics data (DI), Adverse Events (AE), Laboratory Shift, Vital Signs.
• Developed reports using PROC REPORT, Data_NULL_, PROC PRINT, PROC TABULATE.
• Involved in development and using of Macros for continuous and categorical data.
• Developed new or modified existing SAS programs to load data from source and created study specific datasets.
• Used various procedures such as PROC UNIVARIATE, PROC MEANS for categorical data and PROC FREQ for the categorical data analysis as per CDISC ADaM definition.
• Developed statistics about data using PROC LIFETEST, PROC CORR, PROC REG, PROC GLM and PROC NPAR1WAY.
• Generated output files in HTML, RTF and PDF formats using SAS\\ODS.
• Performed ad-hoc reports for data managers, statisticians and medical writers.
• As per GCP guidance comparing original data and observation with transformed/processed data.
• Generated scatter plot, bar chart, odds ratio plot for various data analysis reporting using PROC GPLOT, PROC GCHART, PROC LOGISTIC and high-level annotate facility of SAS/GRAPH.
• Exported dataset in SAS XPORT format for FDA submission.

Environment: SAS/BASE, SAS/Macros, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/GRAPH, Window OS, Oracle9i.

‘Statistical SAS Programmer’- Confidential., Gaithersburg, MD (Jun 2004- Jul 2005)

Project description:
Confidential. is a Contract research organization (CRO) that provides extensive global clinical trials services to pharmaceutical, biomedical and medical device companies worldwide. Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis
Responsibilities:

• Collaborated with bio-statisticians and CDM group to develop, validate clinical trial reporting systems, tables, patient’s data listing, Case Report form Tabulation (CRF), and derived datasets.
• Prepared regulatory datasets from trial CRF by marinating regulatory reference and company’s standard operating procedures (SOP) as per QA group for internal audit
• Extracted data from various source (Oracle, Excel, Access) using SAS facility like SAS/ACCESS and SAS/SQL Pass-through.
• Performed data integrity checks and wrote edit checks programs for data cleaning using SAS Macros and data step.
• Extensively used Data_NULL and SAS procedures such as print, Report, Tabulate, Freq, Means, Summary and transpose for producing ad-hoc and customized reports and external files.
• Created CRT datasets for NDA submissions.
• Applied interleaving, one-to-one reading, concatenating, merging, appending, and transposing (PROC TRANSPOSE & DATA step with ARRAY) techniques for transforming data sets for analysis.
• Extensive use of SUBSTR, INTCK, FIND, INDEX and other SAS functions for data modification.
• Worked on statistical analysis programming for ISS/ISE and CDISC compliant datasets and summary tables.
• Used SAS/ODS facility to write custom safety and efficacy reports directing SAS output to PDF, RTF and HTML files.
• Exporting datasets as per eCTD guidelines for FDA submission, MS application using PROC EXPORT and XML format using PROC CDISC for other regulatory submission.
• Developed efficient and readily modified SAS code using SAS BASE and SAS/Macro.

Environment: SAS/BASE, SAS/Macros, SAS ACCESS, SAS/SQL, SAS/STAT, SAS/ODS, SAS/Report, Window XP, UNIX, Oracle9i, MS-Excel/Access.

‘SAS Data Analyst’- Confidential, (Apr 2002-Aug 2003)

Project Description:
Confidential is leading pharmaceutical company in India involved in investing and manufacturing of drugs for various diseases and disorder. As data analyst, I was involved in data analysis, reporting and CRF document study of pre-clinical study for IND application.
Responsibilities:

• Involved with CDM group and statisticians for Clean the data, Categorize data, Coded free-text data and processing data for analysis.
• Used SAS/Access to Import and Export data to and from MS application.
• Developed adverse event, death, and subject dropout summaries for an Investigational New Drug (IND) application as per 21 CFR 312.33 federal regulations for safety and efficacy.
• Prepared data using data management methods such as if/else statement, DO grouping, SELECT, WHERE statement, ARRAY and SAS functions.
• Imported ASCII text and RDBMS data using SAS PROC IMPORT and LIBNAME.
• Employed techniques like sorting and merging on the raw datasets and coded them using PROC SQL and SAS MACRO facility to get the required output.
• Used SAS Macros and procedures like Proc SQL, TRANSPOSE, TABULATE, UNIVARIATE, MEANS, FREQ for creating summarized table for reporting.
• Generated Listing, PDF reports for presenting the findings of various statistical analysis summary with SAS/ ODS
• DATA step programming for permanently defined labels to data.
• Wrote excel macros using VBA.
• Documented change and modification.
• SAS/GRAPH for various types of graph for analysis and submission.

Environment: BASE SAS, SAS/REPORT, SAS/STAT Oracle, MS EXCEL, VBA, SAS/SQL, SAS/ODS, WIN XP, UNIX.

Master of Engineering – Research in Data analysis for condition monitoring 

Master of Microsystems in Electrical and Computer engineering Dept. 
Bachelor in Instrumentation & Control Engineering