Laxmi Buyyani

Mobile no: 484-***-****

Professional Summary:

Around 9 years of professional experience in Clinical Trial projects and SAS Programming in the CROs, Healthcare and Pharmaceutical industries.

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

Extensively involved in SAS clinical trails &data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to the Standard Operating Procedures (SOPs).

Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS, on Windows and UNIX environment.

Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, 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 (Windows, UNIX, etc.).

Installing and implementing SAS SPDS server environments.

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

Proven skills in data cleaning, data archival, data migration, ad-hoc reporting and coding using SAS on various environments.

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

Exposed to health claim coding systems.

Analyzed data sources for integrity, precision, and accuracy.

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

Thorough knowledge and experience in complete SDLC, GCP and ICH guidelines, SOP’s, 21CFR Part 11 and HIPAA guidelines

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

Review, and negotiation of both generic and site specific informed consents including HIPAA.

Implemented CDISC standards (SDTM) Classes and Domains and used Version 3.2

Good in performing CRF–Annotation with respect to various database designs. Extensive experience in Clinical database setup and eCRF development using Oracle Clinical and Medidata Rave

Strong OC/RDC experience: Development of data entry screen design using character and graphical layouts.

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.

Excellent 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).

Excellent skills in SQL and PL/SQL programming for development of validation and derivation procedures using normal and custom coding in Oracle clinical and Medidata applications.

Experience in conducting trainings on SQL, PL/SQL and Oracle Clinical Applications.

Possess excellent communication skills, ability to perform exceeding expectations, demonstrated ability to quickly learn and teach new concepts, adaptability to change and manage multiple tasks efficiently, exceeding the expectations. 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, fast paced environment.

Technical Skills:

Operating Systems

Windows 95/98/2000/2003 Server/XP, UNIX, MS DOS

Clinical Applications

Oracle Clinical 4.5.3 and 4.6, Medidata Rave

Programming Languages

SAS, SQL, PL/SQL

RDBMS

Oracle 8i, 9i.

DB Tools

Toad, SQL Developer, PL/SQL Developer, SAS/Base, SAS/Stat, SAS/Graph, SAS/Access, SAS/Macro, SAS/Connect, SAS/SQL, SAS/Access, SAS/ODS, SAS/ETL.

Academics:

Master of Technology with distinction from JNTU 2006,HYD- INDIA.

Bachelor of Technology with distinction from OU 2003, HYD- INDIA.

Work Experience:

Novartis – NJ Sep 2015- Jan 2017

Role: SAS Programmer

•Developed programs for Phase I and II clinical trials to create SAS datasets and analyzed Phase II.

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

•Reviewed and provided feedback on case report form designs, CRF annotations, edit checks and SAP.

Used programming tools such as SAS Base (Windows and Unix), SAS MACRO, PROC SQL, Microsoft Excel, etc to develop the application/programs as per the specifications.

•Generated reports using Proc FREQ, MEANS, TABULATE and REPORT.

•Incorporated MedDRA terms in the existing Adverse Event data by creating a mapping Macro.

•Used SAS ODS for generating reports in specific output formats like RTF, PDF, and HTML.

•Created CRT’s (Case Report Tabulations) using CDISC standards for submissions to the FDA.

•Created SAS reports using Proc Report as per FDA regulations.

•Successfully validated TLG’s through independent validation using Proc compare and departmental macros.

•Extracted data from different sources and converted the data into SAS data sets using Proc Sort, Proc

•SQL procedures. Developed macros to map the datasets using CDISC standards.

•Extracted, validated and generated SAS data sets from Oracle using ‘SQL Pass through Facility’.

•Worked on SAS/GRAPH to present results in BAR CHARTS, PIE CHARTS and SCATTER PLOTS.

•Used SAS Macros in creation of new programs as well as modification of existing programs.

•Written programs for checking the metadata quality based on the company provided guidelines.

•Knowledge in Medidata Rave and worked on eCRF development activities.

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/SQL, Oracle Clinical, Medidata RAVE.

Novartis – NJ Dec 2013-Aug 2015

Role: Clinical SAS Programmer

•Involved in documentation of design, Code and Reports for handling over the project.

•Provide clinical programming support and validation for clinical trials in phase I, II & III

•Developed SAS code and Macros to perform data analysis, output tables, listings and figures using SAS Base, SAS Macro, SAS/SQL, and SAS/ODS and also to clean and validate datasets.

•Skilled in merging two or more SAS datasets, preparing and managing data.

•Used SAS/Assist, SAS /ACCESS and PROC SQL to extract SAS data from different relational database management systems.

•Reviewed and provided feedback on case report form designs, CRF annotations, edit checks and SAP.

•Created a report or listings to find the frequency counts of screen failure subjects from Demographic dataset using PROC FREQ, MEANS and PROC report as per the requirement.

•Complete DM, VS domain mapping based on SDTM v1.3 & SDTMIG v3.1.2, and ADSL datasets creation based on ADaM v2.1 & ADaMIG v1.0.

•Knowledge in clinical trial like randomization, sample size calculation, CDISC standard, CDASH, ICH, 21 CFR Part11 regulation, etc.

•Performed validation/Quality Check (QC) of SAS programs using standard operation procedure (SOP) testing.

•Created reports in the style format (RTF, PDF and HTML) using SAS/ODS.

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

•Converted clinical trials raw datasets into SDTM domain based on CDISC and CDASH standards and derived specifications.

•Support clinical data operations including implementing Statistical Analysis Plans (SAP), converting electronic Case Report Forms (eCRF), and coding regulatory data such as Adverse Events (AE).

•Incorporated MedDRA terms in the existing Adverse Event data by creating a mapping Macro.

•Created CRT’s (Case Report Tabulations) using CDISC standards for submissions to the FDA.

•Created SAS reports using Proc Report as per FDA regulations.

•Successfully validated TLG’s through independent validation using Proc compare and departmental macros.

•Extracted data from different sources and converted the data into SAS data sets using Proc Sort, ProcSQL procedures.

•Developed macros to map the datasets using CDISC standards.

•Extracted, validated and generated SAS data sets from Oracle using ‘SQL Pass through Facility’.

•Used SAS Macros in creation of new programs as well as modification of existing programs.

Environment: SAS 9.2, SAS/BASE, SAS Enterprise Guide, SAS/MACROS, SAS/ODS, SAS/Gplot, SAS/ETL, Microsoft Access, Oracle ODBC, Excel.

Client: Novartis Healthcare, IN May 2012-November 2013

Responsibilities:

Role: Database analyst - I

•Development, testing and maintaining of all Global/Disease level Library objects needed for clinical studies like (DVGs, DVG subsets, Questions, Questions Sets and Question Groups). Creation of Global Library Copy Groups of DCMs, DCIs, Procedures, Views and DCI books for reuse of standard pages for individual trials.

•Worked with the Clinical Science Units, DS team to understand the data requirements for collection and submission

•Worked with the Data Standards Governance team to ensure that the data models are consistent with Novartis Clinical Data Standards.

•Worked on review of global SOPs and business guidance / user guides.

•Document, Develop, test and maintain OC validations and derivations procedures using PL/SQL or SQL on CSU/BU standards.

•Creation of Form Layout Templates, Extract Macros and Key Templates for use in individual trials.

•Copied or promoted the study level DCMs, DCIs and Procedures to the GLIB, if approved for re-use by Governance.

•Worked on alignment between OC Global Library Objects and Metadata Repository to maintain consistency.

•Good Knowledge of Novartis Data Clinical Standards, Data Models and its implementation for database and GLIB development

•Subject matter expert in OC.

•Worked with the CSU/BU team on Novartis Clinical Data Standards and OC/RDC setup, including validation procedure development.

•Worked on incident requests (IR) created by the study team to create the global library objects.

•Developed and maintained study specific or common pages required for all TA's. Especially for CVM franchisee.

Environment: SAS 9.2, SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, WINDOWS, Oracle Clinical

Client: Novartis Healthcare Jan 2010-April 2012

Role: ECRF Developer-II

Responsibilities:

•Preparing annotated CRFs using SDTM standards and documentation using MDR

•Designing of database setup using Oracle Clinical 4.5.3 and 4.6

•Creation testing and maintenance of trial specific plausibility and consistency checks.

•Created oracle views for extracting the data from oracle database for creating the SAS datasets in SAS.

•Created data validation and derivation procedures for validation checks in OC

•Provided the data transfer specifications, test transfers and loading third party data for lab using batch data loading.

•Develop database specifications and provide support for outsourced trials.

•Written basic SQL queries to resolve issues with the eCRF applications.

•Worked on data extract specifications.

•Used SAS/Assist to extract data from SAS Files and Oracle Data base.

•Involved in writing code using Base SAS & SAS/Macros to clean and validate data from oracle tables.

•Used SAS PROC SQL to extract data from different relational databases.

•Modified standard programs to generate data sets for statistical data analysis, generate listings, summaries.

•Used SAS Macros extensively in the creation of new programs as well as modification of existing programs to improve ease and consistency of result.

•Analyzed large data sets consisting of millions of records.

•Generated analysis reports, graphs using SAS/Reports.

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/SQL, Oracle Clinical

Client: Asian Clinical Trials 2007-2010

Role: Clinical Programmer

Responsibilities:

CDISC SDTM Experience - mapping of various phases of clinical trial data into the SDTM format.

Develop and maintain programs to meet internal and external client’s needs.

Used SQL Pass Thrufacility to get data from different sources into the SAS.

Retrieved the CRF data in to SAS from the Oracle (CRF databases) using SAS/ACCESS and SAS SQL procedures.

Formatted HTML and RTF reports, using SAS - output delivery system ODS.

Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphs, and listing summaries.

Participated in Program validation and e-submission (CDISC).

Worked on all Data Management responsibilities.

Responsible for providing proper validation, including testing and documentation (e.g., requirements document, program validation), in accordance with GCP and company standards.

Participate in the design and maintenance of a standard programming environment (i.e. file structure and development to production implementation strategy).

Provide timely and efficient technical support to the clinical study teams regarding issues encountered when creating programs.

Assisted, created, modified and developed system level macros and new utility macros for standard reporting in accordance with the SDLC guidelines.

Programming and Validating tables, listings, analysis datasets and figures for inclusion in clinical study reports.

Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/SQL, Oracle Clinical

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