Vivek Ravipati

Clinical SAS Programmer

Contact info-757-***-****

PROFESSIONAL SUMMARY:

• 11+ years of highly experienced Clinical SAS programmer

Worked on phase I Phase II and Phase III of clinical trials and their designs including open-labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.

Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Connect, SAS/Enterprise Guide, SAS/Stat & SAS/Graph.

Extensive experience as SAS programmer in multiple therapeutic areas including Oncology, Infectious disease, Virology, rheumatology, endocrinology, neurology, hematology and cardiovascular disorders.

Hands on experience in eCRF/eCRT package for phase 2 and phase 3 more than 45-50 studies/CDISC SDTM mapping/specs/conversion/domains/datasets/ define.xml development on clinical studies.

Good knowledge of GCP, GPP and US FDA & CFR Part 11 guidelines related to generating the Clinical Reports and Electronic records as well. Experienced in Preparing FDA E-submission ready reporting documentation including creating DDT’s, Transport files (XPORT format files).

Experience involved in Statistics and contribution of end to end SAS programming activities data processing, data collection, quantitative and qualitative analysis (encompassing extracting data from Clinical trial into SAS as datasets to producing the reports viz.).

Expertise in presenting data through standalone applications and building WebPages using asp.net, vb.net, JavaScript and HTML.

Good understanding of regulatory requirements, ICH Guidelines, NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). This includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews and production of integrated safety and efficacy summary (ISS & ISE) for FDA submission.

Experienced in transforming raw data into datasets that are in accordance with SDTM and ADAM standards; Creation of specifications files for creating analysis datasets, TLGs / TLFs and Ad-hoc reports, Develop SDTM data mapping and create SDTM datasets per CDISC standard for FDA.

Excellent skills in statistical analyses and modeling, familiar with common statistical methods for clinical research and Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials.

Experience in preparing NONMEM datasets for POPPK analysis and ER parameters (EVID, NTAPD, NTAFD, ATAPD, ATAFD, DV) another related variables.

Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.

Experience in survival analysis by using procedures like PROC LIFETEST (KAPLAN MIER), LIFEREG, PHREG, LOGISTIC.

Experience in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs; Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development (SDD).

Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results.

TECHNICAL SKILLS

SAS Skills: v8.0/9.0/9.1/9.2,SAS/BASE,SAS/STAT,SAS/MACROS,SAS/GRAPH,

SAS/SQL, S-PLUS, SAS Enterprise Guide, SAS Enterprise Miner, SAS DI Studio,

SAS Web report studio, SAS procedures, SAS BI, Open CDISC validation.

Other Skills: SPSS, Spot fire, R, Qlikview, Sudaan, Strata, S-Plus, MINITAB,MATLAB,ETL tools,ODBC, health analytics using business intelligence tools, Data

Warehousing, Data Mapping, SharePoint, Sigma Stat, Sigma Plot, MS Office

(Power Point, Excel, Access, Word), MS Visio, MEDDRA, ICD-9,ICD-10,

COSTART,EPIC Bridges,HL7, Sarbanes-Oxley, HIPAA.

Databases: Oracle Clinical, MYSQL, MS SQL Server, MS Access, Oracle 11i, DB2.

Languages: C,C++, Visual Basic, VBScript, Java, JavaScript, Python, XML, T-SQL,SQL, PL/SQL, VB.NET, ASP.NET,

PERL,HTML, PHP, Web CGI.

Operating Systems: Windows95, 98, NT/XP/2000, DOS, UNIX.

EDUCATION

Masters in Health Informatics

Saint Louis University, St. Louis, MO

PROFESSIONAL EXPERIENCE

Sr. SAS Programmer Jan2017-Present

Bioverativ (Waltham, MA)

Responsibilities:

Worked both production and QC programming of SDTM datasets, ADAM Efficacy and safety analysis datasets,

tables, listings, and figures, for multiple clinical trials using SAS software.

Expertise in creating eCRT packages - including Define.XML, SDTM Reviewers Guide and Annotated CRF for regulatory submissions (NDA).

Prepared final eCTD documents to be submission ready using the pinnacle 21 runs.

Worked on development ISS/ISE datasets and TLF’s

Working Knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards.

Ensure that standards at a drug program level; integrates data across multiple studies or drug programs.

Meeting the timelines or communicate proactively and effectively if timelines are at risk so that plans can be

Adjusted

Contribute to departmental process improvement initiatives.

Handled a moderate to large volume of complex tasks with minimal and ad-hoc requests with minimal guidance.

Working knowledge of drug development process and clinical trials.

Sr. SAS Programmer Tech Lead June 2016- Dec 2016

ABBVIE Pharmaceuticals, (Waukegan, IL)

Responsibilities:

Developing SAS code for tool development using SAS Macro and PROC SQL, with extensive and applied CDISC knowledge in SDTM and ADaM.

Expertise in developing datasets with current knowledge, guidance and concepts of SDTM :ex: RELREC, SUPPQUAL, CO domain and generate Define.XML.

Developed macros ex :co_derive, BLFL for sdtm_load.sas program, execute, test and deploy.

Tech Lead for Primary development and unit testing of SDTM and ADAM detailed design and deployment.

Used SDLC methodologies, from developing code till deployment.

Reviewed and annotated eCRFs (Case Report Form)

Assisted principal consultant to produce/validate eSubmission (eCRT, eCTD, define.xml) packages.

Independently validated SDTM datasets, AdaM datasets, summary tables and graphs from other programmer

Senior SAS Programmer Sept2014- May 2016

Puma Biotechnology, (Los Angeles, CA)

Responsibilities:

Created SAS programs for SDTM and ADAM datasets for Oncology study.

Created ADAM data sas reports transformed data to webpage and dashborad using the HTML, Javascipt, SAS.

Gathered study team requirements and translated them into technical specifications for SAS programs

Created SDTM datasets for Lab, AE, DM, TU, TR, RS etc., from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.

Created and validated ADaM datasets from SDTM datasets as input, implementation guide and company standards.

Created ADAM datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA.

Assisted with CDISC, SDTM and eCTD module case report tabulations

Worked on preparing eCRT documents CRF Annotations, SDRG, ADRG, define.pdf and define.xml and used pinnacle 21 before FDA submission

Programs for SAS data validation checks and listings to identify data discrepancies

Programmed SAS checks to integrate and reconcile data from external sources (including serious adverse events (SAE), lab results, ECGs, electronic patient records, medical devices and interactive voice response (IVR)) into the primary clinical database SAS datasets

Review Case Report Forms and formatting of SAS datasets extracts for accuracy and consistency

Provide programming support for Annual Safety Reports and Publications

Build standard SAS Macro library

Mentor junior level SAS programmers

Provided Ad hoc statistical programming support

Created Analysis datasets, Tables, Listings and graphs.

Senior Statistical Programmer/Analyst Nov 2013 – Aug2014

Accenture(formerlyoctagon research Solutions), (Wayne, PA)

Responsibilities:

Program, analyze and evaluate clinical data using SAS

Write edit checks from Data Management Plan specifications

Act as quality control programmer to validate SAS programs that produce derived/analysis datasets and analyses specified in the Statistical Analysis Plan

Ensure SAS programs adhere to specifications

Ensure SAS program output matches the requirements of the Statistical Analysis Plan

Ensure specifications and documentation are correct and complete

Assist Data Management in assuring data integrity

Built new MACROS and modified existing MACROS to produce customized graphs using statistical procedures like PROC GPLOT and PROC GREPLAY to include in reports that required FDA approval.

Performed Data Analysis validation and Created the programs to as per the specifications required to run in the SAS drug Development (SDD)

Responsible for QC of derived datasets and statistical results produced by other statisticians.

Created HTML and RTF reports using SAS Output Delivery System (ODS).

Contributed to Case Study Reports (CSR) and documents to be submitted to FDA.

Involved in preparing the necessary submission documents generating metadata in define.pdf, datasets in .xpt format required for regulatory submissions (NDA).

Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, HTML and UNIX.

Senior Statistical Programmer/Analyst Jan 2012 – Oct 2013

Contracting through Accenture

Bristol Myers Squibb Pharmaceuticals, (Princeton, NJ)

Responsibilities:

Worked on phase I, II and III clinical trial studies.

Creation and validation of SDTMdatasets from raw data by following SDTM annotations, implementation guide and company standards.

Creation and validation of ADaM datasets from SDTM datasets as input, implementation guide and company standards.

Reviewand proved effective feedback onProtocol, eCRF, database design, Data Presentation Plan (DPP), SAP and TLF shells.

Creation and validation of Tables, Listings and Graphs by following protocol, SAP and shells as per industry and company standards for regulatory submissions.

Extensively used PROCMEANS, PROC FREQ, PROC ANOVA, PROC MIXED, PROC REG, PROC UNIVARIATEto create outputs based on SAP and shells for statistical analysis of clinical trial data.

Assisted in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.

Used efficient programming techniques to produce and QC derived datasets, tables, figures and data listings.

Developed and maintained general-purpose and adhoc SAS programs/Macros for the validation, Extraction, Presentation, manipulation, analysis, and reporting.

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

Presented data through out the company using the internal website and sharepoint.

Uploaded data to the internal website using the javascript and HTML.

Produced Tables, Listings and Graphs from Integrated data of different studies for Integrated Summaries of Efficacy (ISE) and Safety (ISS) clinical studies.

Coordinated statistical programming team to successful completion of a study within given timelines and resources.

Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros

Create complex and reusable Macros and extensively used existing macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis, and Report generation.

Created SAS transport files for Electronic Submission

Retrieve clinical and lab data from Oracle database and generate SAS datasets.

Reviewed of Clinical data for FDA Submissions

Environment: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, HTML and UNIX.

Clinical SAS Programmer Oct 2009 – Nov 2011

Certus International, Inc., (St Louis, MO)

Responsibilities:

Worked on conversion .XPT files with the data into SAS Data Sets with the SAS Program, PROC COPY IN = tran out-raw by select file name. XPT /MEMTYPE=DATA, for DEM, ECG, AELOG, DOS_SO, ADPAGG, BLEED, CRIT, VISIT and MED.

Imported and converted PKDATA and PKARDATA .xls files into SAS DATA Sets through SAS Application environment.

Developed NONMEM datasets POPPK and ER. POPPK data set derived variables in the analysis data are EPID, DOSE_N, EVID, ATAFD, ATAPD, and NTAPD. and in ER data set are EPID, PTYPE, and ID. Analyzed the Data and generated the Statistical reports with Graphs for POPPK analysis and ER parameters (auc, cmax, tmax, vl, clearance, acc.ratio) for the Pharmacologists to analyze the drug performance.

Development and maintenance of SAS data and statistical analysis programs to support drug development projects.

Data transmission and integrity check of the SAS datasets

Wrote code using SAS/BASE and SAS/MACROS to extract data from ORACLE and MS ACCESS databases.

Using SAS ACCESS defined the oracle database to ODBC to retrieve the data

Produced quality customized reports using PROC REPORT, PROC TABULATE and SAS/ODS.

Provided descriptive analysis using PROC MEANS, PROC FREQ, PROC SORT and PROC UNIVARIATE.

Developed Macros to create tables, graphs and listings for routine reports.

Provided custom data listings, tables and figures for inclusion in Clinical Study Report (CSR) documentation.

Performed statistical analyses using PROC ANOVA and PROC MIXED following the instructions in Statistical Analysis Plan.

Combined and Modified SAS datasets for statistical analysis using SAS data step and procedures including PROC SQL

Created SAS Macros to develop SAS Programs for clinical data Cleaning, Validation, Analysis and Report generation.

Supported Staff programming needs and performed Ad hoc requests.

Environment: SAS 9.1.3 windows, SAS/BASE, SAS GRAPH, SAS ODS, SAS STAT, MACROS,SQL/PLSQL,MS- Excel, MS-Access.

Clinical SAS Programmer Dec2006 - Sept 2009

Globe Immune, Inc., (Louisville, CO)

Responsibilities:

Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets.

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

Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets into SAS

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

Analyzed Phase I, II and III Clinical Trials.

Performed statistical analysis, wrote SAS code for Data Management and reporting, and performed validation, including testing SAS code.

Produced Tables/Listings for Integrated Summaries of Efficacy (ISE) and Safety (ISS).

Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.

Used the SAS Macro facility to produce weekly and monthly reports.

Performed Data Validation and Data Cleaning on Clinical Trial data.

Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.

Created SAS Customized Reports using Data _Null_ technique for FDA regulations.

Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA and other regulatory compliance.

Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.

Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures (e.g., Proc Means, ProcFreq, Proc Report).

Experience in survival analysis by using procedures like PROC LIFETEST (KAPLAN MEIER), LIFEREG, PHREG, LOGISTIC.

Extensive interaction with the functional users to understand the requirements on statistical methods and measures.

Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.

Exposure to Data warehouse applications.

Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.

Produced data listings, summary tables and graphsfor interim and final analyses and publications using different statements/functions/procedure for data manipulation.

Environment:Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, Oracle 8i, HTML and UNIX.

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