Resume

Prasanna Lakshmi. R E-mail: adgn49@r.postjobfree.com

Phone: 571-***-**** Linkedin:www.linkedin.com/in/prasanna-regula-97692357

PROFESSIONAL SUMMARY

●Over 9+ years of experience in the Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 5+ years of hands on experience and professional experience in Clinical Trial projects, epidemiologic studies and also worked as Application Analyst/ERP developer in the CROs, Healthcare and Pharmaceutical industries.

●Experience in analyzing and coordinating clinical data, generating detailed summary reports and data validation using FDA regulation procedures.

●Supported for trial feasibility analysis for oncology and other key therapeutic areas for all Phases.

●Work experience for clinical trial competition analysis, recruitment rate analysis using Citeline product such Trialtrove, Impact data,Ta-scan, clinical trial data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs per the Standard Operating Procedures (SOPs).

●Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS and SAS/ETS on Windows and XP environments.

●Proficient in SAS Macro, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, MergingSAS Datasets, preparing data, producing reports, storing and managing data in SAS.

●Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.

●Working with large volume data warehouses and data access tools and participating database designs of star and Snowflake Data Models.

●Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.

●Creating appropriate (business/technical) documentation for all the programs developed.

●Exposed to health claim coding systems and analyzed data sources for integrity, precision, and accuracy.

●Proficient in working with different clinical trials data like Demographic, Adverse Events (AE), Laboratory, Vital Signs etc.

●Involved in the process of generating TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.

●Prepared scripts to ensure proper data access, manipulation and reporting functions with R programming languages.

●Proven skills in data cleaning, data archival, data migration, ad-hoc reporting and coding using SAS on various environments and also good for ICD-9, CPT, HCPCS.

●Utilized SAS base, SAS SQL and SAS Macros etc. to evaluate statistical data. Compiled regular dashboards with help of Base SAS and Excel macros. Created automated Pivot chart reports utilizing SAS programs.

●Managed data to prepare graphs, tabulations and statistical charts. Designed summary reports with help of various SAS procedures.

●Worked migration projects and good knowledge on converting base SAS data sets in the SAS ETL process.

●Experienced on Creating & Extracting Oracle tables from SAS and within Oracle by using SAS/ACCESS, SAS/SQL.

●Experience in Compliance Reports including IND submissions and NDA Documentation, developed as per QC/QA protocols and FDA guidelines.

●Knowledge in conducting, documenting and reporting computer validation inspections in compliance with 21CFR Part 11(21 Code of Federal Regulations) for clinical trial systems.

●Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).

●Have excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success in a multi-tasking, fast paced environment.

●Imported and exported data files to and from SAS using Proc Import and Proc Export from excel and various delimited text based data files such as .TXT (tab delimited) and .CSV (comma delimited) files into datasets for analysis.

●Participate in system testing by writing, review, and execution of test scripts. Other functions as assigned and participated in migration projects.

●Hands on experience on SAS BI dashboard creation.

TECHNOLOGY/VERSIONS/FUNCTIONALITIES:

SAS tools

SAS9., SAS/BASE, SAS/MACROS, SAS/STAT,

SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/Access

SAS Procedures

SORT, CONTENTS, TRANSPOSE, GPLOT, GCHART, FREQ, MEANS, SUMMARY, SQL, REPORT, TABULATE, PRINT, PRINTTO, SUMMARY, REG, CORR, UNIVARIATE, CDISC

Programming

SQL, RDBMS & JAVA, My SQL

Operating System

Windows98/2000/XP,UNIX

Database

MS Access, oracle 9i & 10G,Oracle clinical, Inform,Impact,CTMS systems

PPM Tool

Planview

IT Service Management Tool

ITSM

Reporting tools

SAP BI & OBIEE.

CERTIFICATIONS

Sun JAVA certified

Oracle Certified Associate.

Base SAS Certified

TRAININGS/CONFERENCES ATTENDED

Attended Oracle summit in 2015.

Attended SAS training.

SUMMARY OF SIGNIFICANT ENGAGEMENTS

Worked in AstraZeneca Pharmaceuticals LP as SAS Developer from Oct 2017 to June 2020.

Worked in The Lacek Group as SAS application Analyst/Programmer from Nov 2016 to Sep 2017.

Worked in ICON CLINICAL RESEARCH as SAS application Analyst/Programmer from Sep 2009 to July 2016.

Worked in Cybermate Infotek as IT Programmer from Jan 2008 to Aug 2009

ACADEMIC PROFILE

B TECH from JNTU University in Computer Science of Engineering (2007) – India.

EXPERIENCE DETAILS

Client: AstraZeneca Pharmaceuticals LP, MD(Maryland), USA

Duration: Oct 2017-June 2020

Role: SAS/ERP Developer

Project: Clinical trials data analysis

Description: Provide hands-on support for trial feasibility analysis for oncology and other key therapeutic areas. Works collaboratively with clinical development and operations teams to provide expertise and analysis support for study and site feasibility assessments and trial planning. Uses advanced trial intelligence tools, information sources and knowledge to analyze trial competition landscape at global, country and site levels. Performs analysis to enable the best, evidence-based decisions and to support clinical study teams in selecting right countries and sites. Contributes to building clinical analytics capability leveraging advanced data exploration tools. Applies the most relevant scientific and technical knowledge at any level of management of information related to clinical trials and related to clinical data excellence to support clinical trial design and clinical operations.

Key Responsibilities:

●Clinical trial competition analysis, recruitment rate analysis using Citeline products such as TrialTrove, Impact data, Ta-scan, clinical trial data analysis using SAS, Sql Server.

●Work with clinical development, clinical operations and external CRO teams to perform advanced trial and site feasibility assessment according to study protocol and pipeline development requirements.

●Assess, incorporate, and curate data and information from available internal and external trial data resources, including Ta-scan, Citeline, KMR, IMPACT and other trial sources. Assess and review other products and data sources as appropriate.

●Perform analyses to understand competitive landscape at product, country/region and site levels internally and externally.

●Worked on Clinical Trials data like Demographics (DM), Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (LB), Vital signs (VS) and Physical Examination (PE).

●Build and maintain key site profile information. Model site performance and identify overused or underused sites.

●Generated Customized Reports using reporting tool PROC REPORT and creating RTF, PDF and HTML formatted files using ODS Facility.

●Involved in creating the In-Text tables for the TLF’s (tables, listings, figures). Created derived SAS datasets as appropriate.

●Experienced in procedures like PROC SUMMARY, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC FORMAT, PROC TABULATE, Data _NULL_ and generating SAS/REPORT

●Developed, Modified and Validated SAS programs and analyzed data using various statistical procedures like PROC MEANS, PROC FREQ, PROC SUMMARY and PROC UNIVARIATE.

●Maintained technical database standards and programming specification documents.

●Worked migration projects and also good knowledge on converting base SAS data sets in the SAS ETL process.

●Keep up to date with literature regarding current and emerging therapeutic drug approaches and trial feasibility research.

● Inform/advise clinical project teams of new findings in supporting trial feasibility analysis.

●Contribute to clinical data review excellence practices among clinical teams. Assess various analytics and reporting tools and methods for analysis and visualization to address clinical data management and excellence business needs.

●Extensively worked on Data mapping from Existing Raw data to CDISC SDTM Standard and review CRFs to ensure consistency with protocol & adequacy in collecting data to meet objectives defined in protocol.

●Used SAS GRAPH from SAS 9.2 to generate the graphs like Pharmacokinetic graphs etc.

●Extract data using the EMR database for patient visits and reports generations.

●Working on issues of various scopes that require both strong clinical or biomedical knowledge and analytics experience.

●Demonstrated good judgment in selecting methods and techniques for obtaining solutions. Interact with a diverse group of internal and external personnel.

Environment: SAS 9 SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Access, Excel 2000, SAS/ODS, SAS System viewer,

SAS/Gplot, Microsoft Access, Oracle ODBC, Excel, Oracle Clinical

Client:The Lacek Group, MN(Minnesota), USA

Duration:Nov 2016-Sep 2017

Role:SAS Developer

Project: EHI (Enterprise Holdings)

Description: This assignment-involves the executing the client's database marketing programs and partnering with other agency practices to provide strategic planning and data insight. and supports marketing initiatives ranging from email campaigns which utilize dynamic customer data, loyalty program and promotion websites, and limited direct mail. Partner teams include consulting services, analytics, and both front-end and application developers.

Key Responsibilities:

●Assess business, data, and technical needs for marketing campaigns and promotions

●Develop a new email template that will be used for on-going campaigns for Enterprise, National, and Alamo brands.

● Executing the database marketing programs and partnering with other agency practices to provide strategic planning and data insight using SAS, Sql Server

●Collect and document data requirements for new campaigns or promotions

●Execute database marketing campaigns with accuracy

●Support team with technical peer review and provide data to support email testing

●Interface with email service providers to stage data for campaign execution

●Work closely with the analytics, account and consulting teams to provide comprehensive data services

●Analyzing the task before doing the configuration.

●Maintaining large data sets, i.e. reading in data from various sources in various formats to create SAS data sets and/or ASCII files.

●Documenting the process, i.e. documenting all the possible information about the application like SAS programs, DATA files and source.

●Preparing project plan for the execution.

●Scheduling batch Jobs and running batch adjustments.

●Creating ad-hoc reports and identifying the tools to use in the process.

●Implementing the process in intervals and testing the process.

●Implementing in production environment and giving access to the minimal number of user’s, to make sure the process works well, before giving privilege to all the users.

●Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.

●Used SAS PROC SQL Pass through Facility to work with DB2 database.

●Used SAS DATA _ NULL_ and PUT statements to create the customized reports.

●Develop new macros for report generation using SAS/Macros as per the customer’s requirements.

●Default Report output is HTML and provided the options of WORD & EXCEL formats using SAS/ODS statements.

●Used FTP to download SAS Formatted Data into EXCEL AND CSV format

●Retrieving Millions of Records Using different Procedures.

Environment: SAS 9 SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Access, Excel 2000, SAS/ODS,

SAS/Gplot, Microsoft Access, Oracle ODBC, Excel, Oracle Clinical

Client:ICON Clinical Research, PA, USA

Duration: May 2013 –July 2016

Role:SAS Application Analyst/Programmer

Project:The ICON Clinical Research Company is a global provider of outsourced drug development services to biopharma, medical device, government, biosimilar and generic organizations. They are involved in discovering, developing, manufacturing and marketing in six major health care areas: cancer, cardiovascular, gastrointestinal, infection, neuroscience, and respiratory and inflammation.

Key Responsibilities:

●Review protocol for Understanding the studies.

●Designing and developing reports for the pharmacy.

●Review CRF’s for Understanding the Structure of the Data.

●Collecting the Raw data From Database into SAS Environment Using Libname Access Method.

●Created CDISC SDTM Domains.

●Data step programming with SAS for data manipulations and calculations used in the Clinical Data Management process.

●Validation of CRT’s.

●Involved in creating reports of Lilly and Pfizer studies.

●Used SAS ODS to produce PDF and RTF, HTML, Excel format files.

●Involved in creating the In-Text tables for the TLF’s (tables, listings, figures).

●Validated Co-Programmer’s work and Programmed for the creation of TLF’s.

●Created derived SAS datasets as appropriate.

●Developed, Modified and Validated SAS programs.

●Analyzed data using various statistical procedures like PROC MEANS, PROC FREQ, PROC SUMMARY and PROC UNIVARIATE.

●Extensively SAS procedures such as Print, Report, Tabulate, Freq, Means, Summary and Transpose for producing ad-hoc and other reports.

●Extracted data from Oracle database, Excel and Access systems to SAS.

●Worked with EMR database and Optum to analyze trial and patient visits data.

●Used procedures like TRANSPOSING, TABULATING, SORTING, etc. in Data transformation and Manipulation processes.

●Created tabular and graphical reports and summary statistics using PROC TABULATE, PROC SUMMARY, PROC PRINT, PROC GCHART and PROC GPLOT.

●Investigated missing data and data anomalies in SAS data sets.

●Able to meet the Deadlines and used modern techniques in programming to improvise and excel.

●Developed SAS programs using SAS /BASE, SAS /STAT mainly sorting and merging using PROC SQL, PROC COMPARE, PROC MEANS, PROC TABULATE, PROC FREQ and various statements.

Environment: SAS 9 SAS/BASE, SAS/MACROS, SAS/SQL, SAS/Access, Excel 2000, SAS/ODS,

SAS/Gplot, Microsoft Access, Oracle ODBC, Excel, Oracle Clinical

Client:ICON Clinical Research, Chennai, INDIA

Duration: Sep 2009- May 2013

Role:Application Analyst

Responsibilities:

●Develop, analyze, coordinate, and assist in the negotiation of contracts and change orders for projects awarded to ICON involving all operational areas with exception of Clinical Operations.

●Develop, negotiate, and prepare contracts and change orders for projects on-going at ICON, by soliciting input and review from key functional areas.

●Work with assigned Clinical Project Managers to establish payment timelines that will allow appropriate processing time for monthly payment runs.

●Overseas setup of APECS budgets for each assigned new study. Update APECS master budget price list with changes from site contracts for assigned studies, as applicable.

●Generate investigator payments from the APECS database, per study’s contractual specifications, including taking data transfer for ICOTrial systems and working with project Managers to resolve discrepancies.

●Perform first level and second level accuracy examination of SOW’s, comparing the paper copies of the forms to the electronic “upload” file, ensuring proper coding in accordance with standard group procedures.

●Administer ICON’s proprietary investigator grants management payments system, ICONomics, to assist users in maximizing the use of the system to improve upon the grants management process for clinical studies.

●Worked as a part of the E-Submission team and contributed towards the Data Cleaning and Data validation of the analysis datasets as per the CDISC standards.

●Manage the ICONomics setup process ensuring ICONomics is implemented and configured to meet ICON’s contractual obligations. Assist with maintaining and enhancing Clinical Application user guidelines and business process documents for the ICONomics system.

●Liaise with Information Technology, Clinical Operation study teams, and investigator contracts and grants administration group resources for supporting ICONomics. Provide support to the Investigator Payments group and study teams to resolve payment discrepancies. Perform support activates in adherence with ICON SOPs, SSPs, and appropriate regulations.

●Assist with administration and maintains tasks for other clinical information technology solutions to improve upon clinical operations management of studies. Process general knowledge of all enterprise clinical systems. Recommend business process improvements.

●Environment: Access 2000/Oracle 9i/Clinical Applications (ICONomics, ICOTrial)/BO reports

Client:Cyber mate Infotek ltd, Hyderabad, INDIA

Duration:Jan 2008 to Aug 2009

Role:Application Support Analyst

Project: The main aim of this project is to address all the major functional areas of hospitals. The Administrator is the authorized person for adding or deleting Categories, Sub-Categories. It has been segregated into eight modules namely Setup, HRMS, Front office, Billing, Hospital administration, Ward management, Investigations and Pharmacy.

Responsibilities:

●Extend technical support to the team members as a level 2 agent.

●Giving Application Support If any issues occur while they are accessing the Application.

●Solving the Priority one and Priority Two Issues for that Application.

●Solved So many Tickets for this Application.

●Good Interaction with users at the time of Solving.

●Reviews the current IT applications, facilities and System interfaces.

●Keep the team informed of the new KBs and the on-going issues by conducting meetings.

●Updating Daily status report to Team Lead

●Giving Application Support for 200 users.

●Contacting end Users through mails regarding the issues.

Environment: JAVA Application/Oracle 9i/ WINDOWS.

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