OBJECTIVE

• Seeking a challenging position in a Data Analysis/Programming environment whereby I can utilize my education, knowledge and skills.

SUMMARY

• Over 15 years of industry experience in the setting up of clinical databases and programming in SAS, JReview Oracle/PLSQL, Visual Basic and Fortran in the Pharmaceutical environment.
• Manage, support and mentor CROs for outsourced studies based on required specifications and protocol requirements, making sure standards are maintained and deliverables are submitted based on agreed timelines.
• Extensive hands on experience in data management tasks like query management, external data reconciliation, AE/ SAE reconciliation etc.
• Comprehensive data management expertise (including all operations tasks and DMP generation oversight and approval)
• Liaised w/ Functional Service Providers (FSPs) and External Data Vendors (LAB, ECG, IVRS, eDiary, IMAGING, BIOMARKER, KRAS etc.) to streamline and improve processes.
• Lead EDC project implementation team from study startup (EDC Kick offs) through Study Go - Live.
• Manage and maintain study timelines and budget.
• Managed post production changes including Amendment roll outs for EDC studies.
• Worked extensively with Clinical Data Standards group to ensure study design is in compliance with SDTM and other submission guidelines.
• Worked extensively with Clinical Development teams to assess the requirements from a database design perspective.
• Provide help desk support to sites to resolve technical issues.
• Extensive experience in reviewing vendor business requirement document for external data setup and preparing Data Transfer Specification to facilitate data integration.
• Expertise in External Data Load setup for a variety of data types.
• Heavily involved in EDC user training and preparation of eHelp and Data Entry Guidelines.
• Hands on experience in preparing and reviewing eCRF requirement documents and Data Validation Specifications (Edit Check specifications) and providing recommendations to the study team.
• Contributed heavily to the to design of CRF's and CRF completion guidelines
• Good exposure to principles of clinical trials (Phases I-IV).
• Knowledge of statistical analysis tools like SPSS, SAS and STATISTICA.
• Program reports and listings to Data Managers and other groups using IReview or JReview software
• Provided adhoc reports during Regulatory agency audits.
• Integrate various third party data into Data Warehouse using Extract Transform and Load (ETL) tools.
• Working knowledge of ICH/ GCP guidelines and Good Lab Practices (GLPs).
• Working knowledge of Clinical Quality Assurance (21 CRF PART 11)
• Hands on experience in freezing and locking (soft lock and hard lock) of clinical databases.
• Experience with Database Development and Administration tools like TOAD and SQL *Plus and SQL Navigator.
• Ability to work on multiple tasks and strong interpersonal, analytical and presentation skills.

PROFESSIONAL EXPERIENCE

Confidential, Morris Plains, NJ

PRINCIPAL CLINICAL SAS PROGRAMMER / REPORT ANALYST

Responsibilities:

• Collaborate with business groups/users to define report specifications and appropriate software to use in creating the report.
• Perform SAS programming to provide data review of complex listings/reports to support Data Management, Medical Coding, Medical Review, R&D and other areas of Clinical functions.
• Perform SAS programming to produce Annual Report for submission to the FDA in eCTD format
• Perform Integrated Summary of Safety and Efficacy programming using Electronic Data Capture (EDC)
• Collaborate with Clinical Data Manager in developing data validation document and edit checks and implementing those checks in Rave database.
• Integrate various third party data into Data Warehouse using Oracle Warehouse Builder (OWB) ETL tool.
• Develop programs for Confidential t profiles and reports to support Medical Review, Medical coding, Drug Safety Monitoring Board and other business units.
• Reconcile safety database with EDC database
• Generate safety reports for Medical reviewer or any other business Unit..
• Create Reports for Clinical Study (CSR), DSUR, Posters, Publications, Abstracts,, IB, PBRER Manuscripts and other visual presentations for conferences.
• Load and reconcile ECG, Biomarker, Central Lab, PK, PD and any other external data.
• Manage External Data Vendors and CROs from study startup to Database Lock.
• Develop adhoc tables and listings and monthly reports for upper management using TIBCO Spotfire.
• Develop and manage Standard Reporting Library for SAS, J-Review, SQL and Spotfire.
• Develop Standard Operating Procedures for Reporting Libraries.
• Supervise and manage other programmers for distribution of workload and submission of deliverables per study timelines.
• Stay current on new reporting software and releases and recommend appropriate adoption
• Collaborate with CRO for all SDTM Domain mappings including aCRF, Reviewer's Guide and Trial Summary for submission to the FDA
• Perform quality checks on mappings delivered by CRO for all Domains
• Perform SDTM validation using OpenCDISC validator v1.5
• Create ADaM datasets for generating TLFs
• Perform any adhoc SAS reports as needed.
• Train any business unit on the use of any software where appropriate and required with applicable access to functionalities.

Environment: Windows, UNIX, SAS/BASE, SAS /MACRO, SAS/ACCESS, Oracle 9i, Internet Explorer 7, PL/SQL, J-Review 12.01, MEDIDATA RAVE 5.6.3, I-REVIEW

Confidential, King of Prussia, PA

PRINCIPAL SAS PROGRAMMER

Responsibilities:

• Creating and executing Tables and listings for FDA Annual Report.
• Program reports and listings as requested by project team Lead for ongoing studies
• Annotate eCRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets. Create data set specifications per specified study requirements, as required.
• Perform SDTM mappings from raw data.
• Perform SDTM validation using OpenCDISC validator
• Create ADaM datasets
• Validate listings and programs using standard validation practices and processes
• Assist with the creation of SAS related project programming and validation documentation
• Assist with the creation of SAS macro and format libraries
• Create reports and listings in support of Data Management Personnel for data cleaning using SAS or PL/SQL.
• Perform reconciliation of all external/third party data
• Develop adhoc tables and listings and monthly reports for upper management using TIBCO Spotfire.
• Trouble-shoots and solves study data delivery issues and/or external data integration issues and/or change request issues using the appropriate applications.
• Attends audits and assists with in-progress audits, including presenting process, procedures and providing any needed validation documentation
• Reviewing and approving User Requirement Specifications (“URS”), Clinical Data Management (“CDM”) conventions, and working procedure documents
• Developing and implementing new CDM systems and enhancements to current CDM systems
• Understand, create and communicate information about creating CDISC-compliant datasets
• Create documentation related to the generation of customer-specific SAS datasets
• Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance
• Assist the Study Quality Representative in the testing of protocol-specific SAS conversion programs
• Assessing and assigning target dates for project timelines in conjunction with VP, Study and Data Operations
• Adhering to target dates for project timelines
• Communicating any changes in target date to appropriate personnel including Project Manager
• Keeping department head informed of current issues
• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Assisting in establishing and enforcing departmental standards
• Participating in the modification of company SOPs related to CDM Services
• Training and mentoring CDM programmers
• Working with internal staff to resolve data and programming issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned
• Maintains Technical and Industry Knowledge by:attending and participating in applicable company-sponsored training

Environment: Windows, UNIX, PC SAS, Medidata Rave, InForm 4.6/5.0, Central Designer, Oracle 9i, Internet Explorer 7, TIBCO Spotfire

Confidential, WOODCLIFF LAKES, NJ

SR. CLINICAL DATA ANALYST

Responsibilities:

• Meet with clinical team to review Protocol and study timelines at study kickoff
• Submit Trial Capacity Request through Oracle Extranet
• Design draft eCRFs using INFORM Central Designer
• Perform Online screen review of draft eCRFs with Clinical Team
• Finalize and submit Database for final approval by Clinical Team
• Develop validation checks and submit to the clinical Team for review
• Program edit checks and perform unit testing
• Deploy Database into QC environment and perform QC testing
• Submit User Acceptance Testing (UAT) Package to Oracle for deployment through Extranet
• Submit UAT link and test users for User Acceptance Testing
• Review UAT log and sign off on final testing
• Submit GoLive Package to Oracle through Extranet
• Post CRF completion guidelines (CCG) in InForm
• Setup Training database for Site Initiation visit (SIV)
• Provide training to Site Users at Site Initiation Visit (SIV)
• Setup and Manage user Accounts and login information through User Management Tool (UMT)
• Provide help desk support to sites to resolve technical issues on timely basis
• Develop data transfer specification (DTS) for external vendors ie. ECG, Central Lab, PK, IVRS, Imaging, Biomarker, KRAS data and all other Special Labs.
• Setup control file/mapping and load data into database.
• Perform reconciliation of all external/third party data
• Communicate with vendors as to timelines and deliverables
• Provides SDTM Programming support for Biostats Group
• Coordinate and support the use of handheld diaries in collection of symptom data from Confidential ts undergoing chemotherapy
• Extract Data into SAS Datasets using JReview for Biostats Group
• Performs Database lock activities
• Request for CRF submit and archival to Oracle for locked studies
• Develop, update and review Standard Operating Procedures
• Collaborate with Team to develop EDC Style manual
• Provide training on IREVIEW and JREVIEW to Data Managers for reports.
• Provide Reports for Monthly Oncology Meeting (MOM Report) using SAS, JReview or Cognos.
• Write up Post Production Changes (PPC) for ongoing studies
• Provide training as and when needed to programmers for any new product like IVRS or IRT system
• Support and mentor CRO in India for outsourced studies based on Eisai’s specifications and protocol requirements, making sure standards are maintained.
• Global experience working with groups in the UK, India and Japan

Environment: Windows, UNIX, Oracle Clinical 4.5.1, InForm 4.6/5.0, Central Designer, Oracle 9i, Internet Explorer 7

Confidential, KENILWORTH, NJ

CLINICAL DATABASE ANALYST

Responsibilities:

• Meet with clinical team to review Protocol and study timelines
• Review final protocol for effective data collection
• Design draft eCRFs using INFORM Architect
• Online screen review of draft eCRFs with clinical team
• Finalize and submit eCRFs for final approval by clinical team
• Review discrepancy document with clinical team
• Program validation checks and unit testing
• Submit UAT Package to IBM for deployment
• Submit database for UAT testing
• Submit GoLive package to IBM for deployment
• Coordinate with external data providers to submit data according to agreed specs.
• Design Clintrial Database
• Develop data transfer files and control files
• Perform metadata updates on ongoing trials through Change Request (CR)
• Manage outsourced studies to CROs

Environment: Windows, UNIX, PC SAS, Oracle 9i, Internet Explorer 7, InForm Architect, Central Designer.

Confidential, NJ

SR. DATABASE PROGRAMMER

Responsibilities:

• Design of electronic case report forms
• Programming of edit checks
• Running of listings and reports
• Perform User Acceptance testing for ongoing studies.

Environment: Windows, UNIX, PC SAS, Oracle 9i, Internet Explorer 7

Confidential, EAST HANOVER, NJ

SR. E-CRF DEV. SPECIALIST

Responsibilities:

• Meet with clinical team to review study timelines
• Review final protocol for effective data collection
• Design draft eCRFs
• Electronic annotation ofeCRFs according to CDISC guidelines
• Review draft eCRFs with clinical team
• Finalize and submit eCRFs for final approval by clinical team
• Follow EDCAP timelines to design database using PHOSCO EDC and Oracle Clinical software
• Review validation document with clinical team
• Program validation checks
• Coordinate with external data providers to submit data according to agreed specs.
• Load external data like ECG, LABS, MRI, IVRS into database
• Meet with clinical team on a weekly basis to review status ofdatabase
• Perform QC testing of database
• Submit database to Data Manager and Clinical Trial Leader for user acceptance testing
• Provide asset management of database to be loaded onto laptops for sites
• Archive database and all associated documentation
• Provide Technical Support for Clinical trial Monitors at various sites
• Global experience working with groups in the UK, India and Switzerland
• Provide interim reports in SAS or SQL to Clinical Team according to Data Management Plan
• Electronic annotation of case report forms
• Design databases in CLINTRIAL using annotated CRFs
• Write edit checks and derivations in PL/SQL for various tables as specified by the Data Management Plan
• Run validation on edit checks in CLINTRIAL MANAGE MODULE
• Resolve discrepancies from CLINTRIAL RESOLVE MODULE
• Submit discrepancies to sites
• Set up COSTART, WHODRL and MedDRA dictionaries
• Maintain periodic updates of dictionaries
• Attach dictionaries to selected panels/tables
• QA final database
• Release protocol into production after database has been tested
• Load lab data using CLINTRIAL LAB LOADER.
• Down load data from CLINTRIAL into SAS
• Load ECG data through PL/SQL loader in MANAGE MODULE
• Review and sign offData Management plan
• Mentor other Database programmers
• Create and amend SOPs and Practices

Environment: Windows, UNIX, Oracle Clinical 4.5.1, Oracle 9i, Internet Explorer 7, Visual Basic, Phosco

Confidential, PRINCETON, NJ

SENIOR DATABASE PROGRAMMER

Responsibilities:

• Setup client protocol in CLINTRIAL 4.1
• Design Client's database in CLINTRIAL using annotated CRF
• Write edit checks and derivations in PL/SQL for various tables as specified by the Data Management Plan
• Run validation on edit checks in CLINTRIAL MANAGE MODULE
• Resolve discrepancies from CLINTRIAL RESOLVE MODULE
• Submit discrepancies to Data Analyst for review
• Set up COSTAR, WHOART, ICD9 and MedDRA dictionaries
• Maintain periodic updates of dictionaries
• Attach dictionaries to selected panels/tables
• QA final database
• Release protocol into production after database has been tested
• Load lab data using CLINTRIAL LAB LOADER.
• Down load data from CLINTRIAL into SAS
• Run SAS listings
• Review and sign offData Management plan
• Supervise Junior Database Programmers
• Train new personnel in Data Management Procedures
• Work with global groups based out of UK

Environment: Windows, UNIX, Oracle 9i, Internet Explorer 7, SAS BASE, Clintrial

Confidential, RARITAN NJ

Jr. SAS PROGRAMMER

Responsibilities:

• Down load data from ORACLE database
• Create SAS Data sets
• Perform ANALYSIS ON ADVERSE EVENTS, LAB AND SAFETY DATA.
• Preparation of data listings, summary tables and graphs using PROC PRINT, PROC TABULATE, PROC REPORT, DATA NULL AND PROC PLOT
• Perform VARIOUS MERGES ON DATA SETS
• Use various graphics programs, word processing systems and print procedures in report presentation

Environment: Windows, UNIX, Oracle 9i, Internet Explorer 7, SAS BASE