PROFESSIONAL SUMMARY:

• 9+years of Industry experience as a Sr. Business/Data Analyst with solid understanding of Business Requirements Gathering, Business Intelligence, Data warehousing, Data Mapping, Data Validation, Data Integrity, Master Data Management (MDM), Reporting, Data Governance, Data Stewardship and Data Modeling.
• Experienced in data analysis, data modeling, Conceptual logical modeling and physical database design for Online Transactional processing (OLTP) and Online Analytical Processing (OLAP) systems.
• Extensive experience in conducting Market Research, Feasibility Studies, Data Analysis, Data Mapping, Data Profiling, Gap Analyses, Risk Identification, Risk Assessment, Risks Analyses, and Risk management.
• Researched data issues and identify the root cause in source systems, data warehouse and data marts using various data analysis techniques, data profiling and data mining activities.
• Expertise in broad range of technologies, including business process tools such as Microsoft Project, Primavera, Promodel, MS Excel, MS Access, MS Visio, technical assessment tools, Data Warehousing concepts and web design and development.
• Expertise in Business Process Modeling, Business Process Re - design and in designing Process Architecture.
• Experienced and professional employee with knowledge in regulatory compliance, GMP, Quality Assurance Audits, Document control, Quality Assurance/Quality Control activities in the pharmaceutical
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries and cGMP, GCP, GLP, CAPA, GRP, EMR, EHR & QMS.
• Highly proficient in working with users to gather requirements, analyze them and subsequently use the Rational project and design tools to model the requirements.
• Strong expertise in FDA regulations, GxP suites (GAMP4 & GAMP5, GDP), Computer System (CSV) & Equipment Validation, Documentum, LIMS and Trackwise.
• Conducted JAD sessions, created Use Cases, work flows, screen shots and Power Point presentations for the Web Applications and maintained product quality under GMP and ISO 9000 requirements.
• Responsible for documenting workflows and resulting business analysis into a Business Requirement Document (BRD) and obtaining sign-off from the client on the specifications for use within the Request for Proposal (RFP).
• Performed Good Laboratory Practice (GLP) audits on research data books and conducted GLP .
• Analyzed potential GMP issues and determined whether an event or investigation was warranted.

DISCIPLINES:

Business analysis, Data Analysis, Project Management, Business Architecture, Data Warehousing, Data Integrity, Data Mapping, Data Modeling, Requirements Gathering, Functional Specification Design, Testing (Test Cases) (Manual Testing & Automated Testing tools), Quality Assurance (QA), Documenting Process Flow, Process Re-Engineering, Process Mapping, Business Contingency/ Business Continuity Planning (BCP), GAP Analysis, SDLC

TECHNICAL SKILLS:

Software/Hardware : Rational Team Test, OOAD (OOA/OOD), RUP, UML, Rational Rose, Rally, Clear Case, Clear Quest, WinRunner, Load Runner and Test Director, C, C++, Java, HTML, J2EE, VB, SQL, Windows 9x/NT/2000/XP, Unix, Linux, Solaris, Oracle, SQL Server and MS Access, SPSS, RDBMS, DB2, Teradata, Mainframe, JSON, TSL, SQL Basic, Shell Scripts, Crystal Reports, Cognos, MS Visio, MS office, Adobe PageMaker, Adobe PhotoShop, MS Project, Waterfall, Agile, Adobe workflow systems, Weblogic Server, iRise, Mercury Quality Center, MS SharePoint Server, Quick Development Case and Quality Review Tool(QDQ), Informatica Data Quality (IDQ), Master Data Management (MDM), Microstrategy, Business Objects, ETL.

PROFESSIONAL EXPERIENCE:

Confidential, Waco, TX

Sr. Business Analyst/Data Analyst

Responsibilities:

• Strong experience in the Data Analysis, Data Profile, Data Quality, Data Integrity, Design, Development, Implementation and Testing of Business Intelligence applications using ETL and ELT methodology.
• Performed data analysis on source data to be transferred into a MDM structure.
• Performed data analysis and ran various SQL queries to critically evaluated test results.
• Advanced ad-hoc and standard report development, including data analysis through the use of Oracle Discover, Business Objects, TOAD, Erwin, Excel, Access, SAS, SPSS, SQL, and Oracle Reports.
• Led development and documentation of data governance policy and procedures as well as Stewardship inventory.
• Used Microsoft Visio for Business Process Modelling and Data flow diagrams.
• Used Master Data Management (MDM) technology, tools to create and maintain consistent and accurate lists of Master Data. Used senior level SQL query skills (Oracle and TSQL) in analyzing and validating SSIS ETL database data warehouse processes.
• Extensive experience with Data Warehousing, Extraction, Transformation and Loading (ETL) and Business Intelligence (BI) tools (Qlikview and Tableau).
• Developed reporting specifications by identifying business needs, prototyping sample reports and mapping data elements from reports to data models.
• Data integration’s assessment from Bach Records according to ALOCA + guidelines.
• Experienced in Documentation and validation of Electronic Batch Records (EBRs).
• Developed strategy for managing identified utilization patterns for online portal for PBM (Pharmacy Benefit Manager) Implement and perform outcomes analysis for above strategies.
• Created Source to target data mapping documents identifying key data elements and prepared Data Flow Diagrams
• Document analyses on MBR and EBR.
• Worked for a large sized pharmaceutical company. The project includes creating a commercial pharma data warehouse platform, which acts as a single source for processing, managing, accessing and reporting all the data related to commercial requirements of the client for all of its products/franchises.
• Handle batch processing file scripts to auto update the database and backup process.
• Defined and documented the vision and scope of the project for Data warehousing and BI Analytics.
• Performed data mining in Business Warehouse and SAP to create customized sales analysis reports for management
• Conducted meetings periodically with various stakeholders at various phases of the Manufacturing Process Flow to discuss open issues and resolve them.
• Created validation transfer plans for four separate assays while collaborating with Marketing, R&D and Manufacturing.
• UAT database load testing by creating and executing queries.
• Strong understanding of various PMO techniques used in SDLC such as Rational Unified Process (RUP), Waterfall, Agile and SCRUM with hands on experience in each of them.
• Prepared presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
• Implemented Rational Unified Process (RUP) and Business Process Mapping (BPM) across the organization.

Environment: SmartLAB, Track & Trace, SAP Fieldglass, MS office, MS Word, MS Excel, MS Visio, Windows XP Professional, Oracle, Tableau, XML, RUP, Oracle, UML, PL/SQL, Business Objects, ETL, Oracle, Mainframes, COBOL, Veeva.

Confidential, Groton, CT

Sr. Business/Data Analyst

Responsibilities:

• Conducted data Mapping and data base change sessions, Identified the existing data fields in SharePoint data mart which is the centralized database for Aventis applications and required data fields for TEN application.
• Extensive experience in Data Analysis and ETL Techniques for loading high volumes of data and smooth structural flow of the data.
• Experienced in data analysis with solid understanding of Business Requirements Gathering, Data warehousing, Business Intelligence, Data Mapping and Data Modeling.
• Have considerable expertise in Metadata Management, Data Analysis, Data Integrity, Data Acquisition, Data Steward, Data Mining, Data Profiling & Quality, Data Governance and Master Data management (MDM).
• Debugging and Troubleshooting improper data. Validating the data provided by client and ensure Data Integrity.
• Assisted Business users to understand data flow across different modules of the project.
• Used Confidential ’s current Test Cases to identify gaps in coverage and supplement the test suite with test cases that will verify and validate data points and integrations.
• Used SAS for pre-processing data, SQL queries, and data analysis, generating reports, graphics and statistical analysis.
• Used Microsoft Visio for Business Process Modelling and Data flow diagrams.
• Used Tableau to track KPIs and prepared statistical reports for each product (each client) outlining marketing cost vs incoming revenue on a weekly basis.
• Created DTS Packages for migration of data between MS SQL Server database and other databases like MS Access, MS Excel and Flat Files.
• Created conversion scripts by writing SQL queries and PL/SQL procedures using TOAD or other comparable SQL development tool for Member Management.
• Responsible for 24x7 coverage for various mainframe based Cobol applications using DB2, VSAM and IMS databases.
• Managed a project team of internal and external resources to successfully upgrade the Nautilus LIMS for High Throughput Organic Synthesis and Purification Labs yielding new functionality and increased system performance.
• Set up and instituted InVitro robotics laboratory for DMPK including programming, validation and .
• Conducted critical DMPK assays to support preclinical and clinical development in accordance to regulatory guidance.
• Managed an analytical laboratory and supervised staff scientists to conduct DMPK studies.
• Responsible in RFP requirement gathering for System Integrator, Managed Care, Provider modules.
• Responsible for LIMS analysis, configuration and support. Authored and reviewed the validation lifecycle deliverables such as Requirement Specifications (User and Functional), Configuration Specifications, Validation Plan and Testing documents and Summary Report. Review and approve product specification in Laboratory Information Management Systems
• Identified and documented business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate data exchange.
• Managed internal R&D and client sponsored web-based projects.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Worked on pharmacy benefit management systems (PBM) to make use of our existing web applications that provide pharmacy/Rx related member functionality.
• Offered frozen and aseptically filled flexible containers for pharma products and clinical-scale and commercial-scale vial and syringe fillings for pharmaceutical customers.
• Directed the oracle clinical trial data capture and worldwide data collection systems for various therapeutic areas.
• Informed key stakeholders of LIMS project status, issues, problems, and proposed solutions.
• Interacted with various departments in the hospital and Lab to gather requirements using different applications like Trackwise for Laboratory Information Management Systems (LIMS) and EPIC modules.
• Involved with all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle.
• Accounts” and “Swift Message Generation” at ORACLE using SQL queries and PL/SQL program units
• Wrote test scripts for User Acceptance Testing (UAT).

Environment: Windows XP Professional, Oracle, PL/SQL, MS Access, MS Excel, RUP, Oracle, Tableau, UML, Rational Rose, Requisite Pro, Clear Case, Rational Clear Quest, MS Office suite, MS Visio.

Confidential, Lyndhurst, NJ

Business/Data Analyst

Responsibilities:

• Performed data analysis and data profiling using complex SQL on various sources systems including Oracle and SQL Server.
• Performed in depth data analysis identifying data issues in legacy system and worked with business to develop resolutions to those issues.
• Experienced working in the area data management including Data Modeling, Metadata, Data Analysis, Data Integrity, Data Mapping and Data Dictionaries.
• Monitored Strategies, Processes and Procedures to ensure the Data Integrity, Optimized and reduced Data Redundancy, maintained the required level of security for all production and test databases.
• Used Data Integrator to load data from various sources such as MS Access, MS Excel, CSV files to MS SQL Server.
• Extensive knowledge of RDBMS, Web and SQL along with MS SQL administration, SQL Enterprise Manager, Data analysis and reporting.
• Experienced in utilizing statistical tools like SAS, SPSS, MS office suite, MS projects, MS Visio and requirement management tools.
• Implemented Master Data Management (MDM) for all entities in the project by maintaining a master hub for improving the data quality by following various data governance techniques and data dictionary standards.
• Extensively used Tableau features like Data blending, Extracts, Parameters, Filters, Calculations, Context Filters, Hierarchies, Actions, and Maps etc.
• Reviewed IMS data for new market entrants and changes in competitive landscapes.
• Gathered requirements relating to the configuration of the EDC and CDM system - RAVE, ECRF (Electronic Case Report Form) design, clinical trial reports and output data extracts.
• Worked on CDM (Clinical Data Management) project for commercial line of business.
• Extensive experience in Clinical Data Management, data analysis and generated CRT tables, reports, graphs for FDA submission according to protocol.
• Manage implementation of BioBook and ActivityBase Electronic Lab Notebook (ELN) products to support the scientists/biologists of the R&D Dept. of Pharmaceutical customers.
• Design, develop, test, debug and implement new functionalities in SQL*LIMS by coordinating with business users and client manager.
• Configured laboratory information management systems, such as LabVantage SQL LIMS,developing validation master plans and validating LIMS implementations
• Designed and developed project document templates based on SDLC methodology
• Ensured quality, safety and environmental standards and procedure compliance, and coordinated monthly OSHA Environmental, Health and Safety meetings
• Extensive experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including thorough knowledge of SAS Macro.
• Worked in an AGILE delivery model involving multiple scrum teams and daily stand-up meetings

Environment: Java, UML,Requisite Pro, SAS, ClearCase, ClearQuest, HL7,WinRunner, Load Runner, Agile/Scrum, Rational Clear Case, Perl and Oracle on Windows NT, PL/SQL, and UNIX, Tableau, Labware LIMS, Web LIMS, Oracle, LIMS Basic, OOAD, Windows XP Professional., LabVantage, Oracle.

Confidential, Huntsville, AL

Business/Data Analyst

Responsibilities:

• Performed Requirement Gathering & Analysis by actively soliciting, analysing and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Worked as a Data Analyst for ETL projects that extract data from various source systems for subject areas - Revenue, Billed, Medical Claims, Pharmacy Claims, and Capitation.
• Involved in analysis of requirements for Medical and Commercial line of businesses.
• Expert in data related to voluntary benefits and advised in cross functional projects to ensure data integrity.
• Proficient in writing SQL queries for data analysis and validation.
• Worked with end users for BI data analysis and data validation. Responsible for Master Data Management (MDM) and Data Life Cycle process. Worked on heterogeneous data coming from multi sources including Flat Files, CSV files, XML Files, Mainframe Files and DB2UDB. Worked on data analysis and validation.
• Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database.
• Experience with designing and verifying databases on Oracle and SQL Server RDBMS using Entity-Relationship Diagrams (ERD).
• Created, updated & maintained Electronic Batch Records (EBR) for multi-million dollar live virus vaccine products using MES (PAS-X Werum).
• Interfaced with Manufacturing, Quality, R&D organizations and integrated new products and processes into the existing manufacturing area.
• Gathered requirements from various audits groups - GMP, GVP, CSV, GCP, GxP, REMS, IT SOX.
• Performed Environmental Monitoring and Conducted routine audits of data, Information, procedures, Equipment and Systems To Ensure Compliance of SOP, GMP and other Regulatory Requirements.
• Involved in data migration from the existing system Cerner (Internal Application for Account Receivable and Coding) to new system IMS (Intelligent Medical Software).
• Involved in testing the Pharmacy Claims adjudication and Billing processing is done through PBM (Health Trans) and Claims Accumulation and Adjudication is done through Diamond.
• Participated in Salesforce.com and Veeva, Master Data Management (MDM), Customer Data Integration, Roster database upgrade and other significant Siebel related projects.
• Involved in Identifying user Requirements and Analyzing the Existing Data Source and IMS data to Build Product Platforms into Standardized Data warehouse/Datamart.
• Informatica Data Quality (IDQ) used for data quality measurement.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Created data governance and privacy policies specifying contract implementation.
• Assisted the database development team in data modeling, data structure and data table layouts required for consolidation of incongruent databases,
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Directed the oracle clinical trial data capture and worldwide data collection systems for various therapeutic areas.
• Tested the ETL Informatica mappings and other ETL Processes (Data Warehouse Testing)
• Wrote test scripts for User Acceptance Testing (UAT).

Environment: Windows XP Professional, Oracle, Tableau, XML, SOA, MS Access, MS Excel, MS Visio, MS project, RUP, Oracle, UML, Rational Rose, Requisite Pro, Clear Case, Rational Clear Quest, MS Office suite, MS Visio, PL/SQL, Business Objects, ETL, Oracle, Mainframes, COBOL, Veeva.

Confidential, Durham, NC

Business/Data Analyst

Responsibilities:

• Performed data analysis, created data mapping and data interface documents and kept the documents updated with changes in requirements and functional specifications.
• Performed data analysis, data reconciliation and data retrieval from various systems along with identification of data gaps and data quality.
• Prepared test Data sets and performed data testing using the PL/SQL scripts. Also used MS excel for data mining, data cleansing, data mapping, Data integrity and data dictionary and data analysis.
• Resolved data integrity and quality exercises to reconcile data from Master Data Management (MDM).
• Worked with the ETL data warehouse and BI teams while developing data marts, data models and while reporting and data mapping & validation and wrote SQL queries, prepared dashboards and performed data analysis.
• Utilized SAS procedures and other SAS applications for data updates, data cleansing and reporting.
• Involved in executing the test scripts to test the interface between SAP and LIMS system.
• Participated in all the phases of SDLC and involved in creating Validation protocols.
• Performed Deviation investigations, worked on writing SOPs and Quality System Development processes.
• Involved in preparing, executing and defending Remediation Plans, Change Controls, Change reporting Requirements, Design Specs, Traceability Matrices, IQ, OQ and PQ protocols and summary reports for spreadsheets.
• Worked particularly on LIMS, handling data for lab and also processing, tracking, storing and reporting various analytical data and records. I worked both on static data and dynamic data.
• Developed Test cases for LIMS and tested the LIMS application.
• Documented and reviewed all the laboratory records through LIMS and controlled forms following the GLPs.
• Implemented GxP and GAMP guidelines in the systems.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of User Acceptance Testing (UAT).
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the 21 CFR Part 11 regulations.

Environment: Requisite Pro, Rational Rose, Oracle, PL/SQL, HTML, MS Office, MS Visio, EDI, UML.

Confidential, San Rafael, CA

Business Analyst/Data Analyst

Responsibilities:

• Acted as a team with multiple pharmaceutical companies to verify stability of medications.
• Maintained pharmacy inventory by checking pharmaceutical stock to determine inventory level anticipating needed medications and removing outdated drugs.
• Simultaneously managed multiple SDLC enhancement projects in Pharmacy Benefit Management System (PBM).
• Performed extensive data analysis with other functional analysts on data received from various sources and in different formats.
• Used Microsoft Visio for Business Process Modelling and Data flow diagrams.
• Facilitated Data Governance Steering Committee sessions to drive decision making.
• Defined accountability procedures governing data access, processing, storage, retention, reporting and auditing measuring contract compliance.
• Created and executed integrated territory business plan that incorporates analysis of the product and market trends in the territory (e.g. patient flow, reimbursement, healthcare system makeup of territory, etc.)
• Performed data mining in Business Warehouse and SAP to create customized sales analysis reports for management
• Developed fully documented test and validation plans, preparation and execution of IQ, OQ, documentation of Test and Validation reports, Test Defects, and Traceability Matrix
• Conducted JAD Sessions periodically with various stakeholders at various phases of the Software Development Life Cycle (SDLC) to discuss open issues and resolve them.
• Involved in generation and execution of SQL queries.
• Performed Web Page Mock-Ups using MS Visio and thus defining the Business Process Model and Data Process Model.

Environment: Mainframes, COBOL, JCL, Visual Basic, Oracle, Teradata, UNIX, Rose, MS office, Cognos, MS Word, MS Excel, MS Visio, SAS, Requisite Pro, Load Runner, Win Runner