SUMMARY

• 5 years SAS/SQL (Bio-Pharmaceutical/ Healthcare industries) Well-developed communication and problem-solving skills with the ability to resolve difficult situations under adverse conditions.
• 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 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.
• Programmed analysis datasets, pooled datasets, listings, summaries, figures and tables for the reporting and analysis of the clinical trials and of the ISS andISE according to client specifications.
• Experience in validating SAS Datasets, Tables, Listing and Figures using Proc Compare Procedure.
• Having good 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_ .
• Exceptional ability in problem solving, data analysis, reports generation with macro and data transfer between different environments.
• Experienced in transforming data imported from disparate data sources into analysis data structures, using SAS functions, options, ODS, 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.
• Familiarity with WHO Drug Dictionary, MEDDRA.
• 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

Therapeutic Areas: Cardiology, Diabetes, and Oncology.

EDUCATION

M.S Botany (major in microbiology).
B.S Environmental Science.

CERTIFICATIONS

Diploma in Cell and molecular biology.
Certification in Bioinformatics.
Diploma in Oracle Developer suite, Oracle Forms & Reports.

TECHNICAL SKILLS

SAS tools: SAS v8/v9, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/CONNECT, SAS/ ODS
Database: Oracle clinical, SQL server, MS Access, Oracle 8i/9i.
Operating system: windows 98/2000/NT/XP
Tools: SQL/PLSQL, SQL*Loader, MS-Office (Word, Excel, PowerPoint)

PROFESSIONAL EXPERIENCE

Confidential, Philadelphia PA
(Biometrics dept)
Nov 2008 - Dec 2009
SAS Programmer

Responsibilities:

• Performed assigned SAS programming required for clinical trial analysis and reporting, developing the Statistical Analysis Plan, as assigned.
• Provide programming support to produce tables, listings, graphs based on SAP/protocol for CDISC compliant databases (e.g. STDM) for regulatory submissions is preferred
• Assisted in validating SAS Datasets, Tables, Listing and Figures using Proc Compare Procedure.
• Ensured that programs are documented in accordance with Company SOP/Working Guidelines.
• Extraction and creation of data sets using SAS/Access, SAS/SQL from large-scale databases ( Oracle 8i/9i, Oracle Clinical 4.0/4.5)
• Assisted in processing, cleaning, quality assurance, and review of clinical study data.
• Participated in programming tasks using software other than SAS (e.g SQL, toad) to support Biometrics or specialized data analysis requirements
• Participated in statistical program validation and quality control activities, as assigned
• Provide statistical support to other disciplines related to clinical statistics.
• Assisted in designing/developing SAS macros and other utilities to expedite SAS programming activities, generated tables, listings, and graphs per protocol, Statistical Analysis Plan, and/or approved client request.
• Programming of analysis datasets, pooled datasets, listings, summaries, figures and tables for the reporting and analysis of the clinical trials and of the ISS and ISE according to client specifications
• Assisted with group and departmental Quality Control (QC) procedures, all other projects as assigned.
• 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.
• Developed SAS macros for data cleaning and reporting and to support routing processing.
  

Environment:
Windows NT server, BASE/SAS, SAS/MACRO, SAS/SQL, SAS/STAT, Oracle Clinical 4.0/4.5

Confidential, NC
Feb 2007 - July 2008
Clinical Data Associate/ Programmer

• Importing/Exporting data, routinely and ad-hoc for multiple studies, keeping data up-to-date for study team
• Creation, Testing, and Validation of Edit Check Specifications, adhering to protocol, variable specifications and departmental standards.
• CRF Conventions, Data Entry Guidelines, and SDV (Source data verification).
• Communicating with study team to ensure progress of studies, supporting them from study start-up to database lock.
• Interacted with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
• Programmed data cleaning checks, as necessary, to facilitate Data Management's data cleaning activities.
• Assisted in review process of study documents such as the CRF, edit specifications written by Data Management, and Statistical Analysis Plans, as needed
• Generating and Reviewing study reports and listings, ensuring data quality, consistency and study timeliness.
• Reviewing, and Resolving Queries as well as Verifying and Validating data performed by Data Entry screens testing, auditing first and second pass, data retrieval.
• Liaised between data entry and management, participated in Data entry for timely completion of project.

Environment:

Confidential , PA
Apr 2006 - Jan 2007
Associate SAS Programmer

Healthcare firm that provides patient-centric, longitudinal data, managed care information, pharmaceutical marketing, long-term care information, analysis, generic efficiency, true patient measures, pharmacy benchmarking, data cleansing, medical data, healthcare claims data, opinion leader mapping and client services

• Developed programs to generate Provider Profiles for Gov. Submission, for the insurance Claims, Clinical Quality Reports to meet the Standards in addition to the ad hoc programming for several departments from within and outside the organization.
• Perform data capture, entry, processing, retrieval, and analysis of medical data, develop and manage data loads, and provide user support as needed.
• Assisted in programming, prep-cleanup-convert data, as well as test and monitor data quality.
• SAS BASE, SAS/SQL, SAS/ODS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, and SAS/MACROS were extensively used for programming applications.
• Proc Report, Proc Tabulate, Data-null-techniques used to generate highly customized reports and SAS ODS was used to submit the reports.
• Tested and Debugged against the test data. Used SAS for pre-processing data, data analysis, generating reports, statistical analysis and graphs.

Environment: SAS BASE, SAS/STAT, SAS/SQL, SAS Macro, SAS/ACCESS

Confidential, Bangalore INDIA
Jun 2005 - March 2006
Assistant Data Analyst

Confidential is a recognized laboratory dedicated in the study and analysis of specimens, subject matters with respect to its various clients in pharmaceutical, clinical, biotech industries.

• Initiate, build, grade, and track data quality through periodic auditing of both new and existing data sources.
• Used proprietary software to import and process incoming data.
• Generated reports for internal and external customers.
• Reviews and reconciles reports to ensure record accountability and ensure that all system processing is properly performed.
• Document procedures and systems, Initiates automated scripts to download information from Internet sources. Monitor personal computers to ensure automated scripts are functioning properly.
• Manually preprocesses selected files to prepare them for automated data processing.
  

Confidential, Bangalore INDIA
April 2003- May 2005
Associate Programmer

Confidential, is a pharmaceutical and bulk drug industry leading in drug manufacturing, research & development of generic drugs with units located worldwide.

• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.
• Converted flat files excel data into Oracle datasets as per requirements using SQL*Loader.
• Extensively involved in getting data from oracle database using SQL pass-through. Created tabular, cross tab reports using Oracle Report Writer.
• Involved in Data validation, analysis datasets, tables and listings using Procedure compare and code walk-through.
• Analyze and load data samples of specimens in the Customer database using SQL* loader to load data from CSV (comma separated version) files, Excel pivot tables.

Environment:
Windows 2000, Oracle 8i, Report Writer, SQL*plus, SLQ*Loader

Confidential, Bangalore INDIA
July 2001- May 2003
Research Assistant

Projects undertaken:

• Extraction and separation of isoenzymes and proteins from infected peanut leaves using SDS-PAGE.
• Isolation and characterization of Streptococcus sps from throat swabs of children age 3-13.