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 patient 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
• 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 patients 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