Vasudha Dronumraju

Sr. SAS Programmer

Email: ac8kqe@r.postjobfree.com

Phone: 317-***-****

Summary:

Expert knowledge and experience of more than 6 years with SAS programming and reporting in clinical trials.

Extensive SAS programming experience in Phase I, II and III of Clinical Trial Data

Experience with Clinical study methodologies, Exposure to Phases I/II and III of Clinical Trials and Electronic Submissions in various therapeutic areas

Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS

Good experience in Clinical Data Analysis: analyzing clinical data, derived datasets, creating tables, generating listings, reports and graphs

Excellent oral and written communication skills. A quick learner with an eye for detail and excellent analytical and quantitative skills.

Performed various QC/ Validations for datasets and TLG’s.

Proactive problem solver, devising solutions that fully support the bottom line and long-range goals. Catalyst for continuous improvement who readily adapts to evolving business and technology challenges.

SAS Developer Created SAS programs, drivers and macros for antiviral clinical tables and listings.

Summary of experience:

Optum Pharmaceuticals, Remote Jan 2017- Present

Sr. SAS Programmer

Responsibilities:

Oversee the clinical SAS programming and analysis functions and support for the entire clinical studies across multiple protocols for the submissions such as CSR and Safety

Demonstrate proficiency in coordinating wide range of professional functions such as generating tables, listings, QC checking, and validating all outputs for clinical trials; developing reports for Safety and efficacy as per study requirements; debugging SAS compiling errors and identifying issues; producing reports or analysis data sets; and SAS data sets and other database management

Play a key role in developing, debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings in accordance with departmental standards

Perform extensive QC (Quality Check) and analysis in reviewing other team members work as well as render primary support and assistance in data validation and data cleaning in all phases of Clinical studies

Facilitate the modification and development of existing SAS programs as well as accountable for the creation of new programs using SAS Macros

Work collaboratively with statisticians and clinical data managers in analyzing the Clinical Trials and generating Reports

Render support in generating analysis data sets and creating specified structure of TLFs through creating Macros and macro variables using %LET, CALL SYMPUT, and DATA _NULL_

Generate analysis datasets based on the Data Definition Tables (DDT) and in accordance to the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.

Utilize Proc CDISC for verifying compliance of datasets with CDISC standards and electronic submissions

Experience in working on multiple protocols and/or drug compounds at a time

Vertex Pharmaceuticals, Boston, MA, Oct2016- Dec 2016

Statistical Programmer:

Responsibilities:

Extensively involved in development of SDTM domains as per the SDTM IG 3.1.3/3.2 standards with the help of annotated CRF and Specifications provided by the client

Performed verification of SAS-generated outputs (table, listings and graphs) via Independent programming.

Leveraged industry expertise in providing topnotch SAS Programming and analysis support for phase III clinical trials

Served as primary SAS programmer and collaborate with statistician in analyzing initial data sets and generating tables, listings and figures (TLFs) for clinical trials

Managed day to day technical operations such as creating tables and graphs to produce clinical study reports based on collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP)

Proactively performed and managed various duties such as data transformation and manipulation processes; ORACLE database management; creating and modifying new and existing SAS programs; and producing Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs);

Led the development of SAS code for modeling data and directed the implementation of SAS/STAT procedures such as Proc Lifetest, Proc lifereg, Proc Phreg, proc reg and Proc Glm for Survival analysis, logistic regression analysis and other statistical analyses

Meticulously analyzed and validated data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ. Created formats for the coded data and used PROC SQL for data validation

Oversaw the daily tasks associated with clinical programming and subsequent analysis to ensure sponsor deliverables are created per agreed timelines and to high quality standards.

Involved in review of Define.xml (Case Report Tabulation Data Definition Specification)

Required for the FDA submission.

InVentive Health Mar 2016- Sept2016

Sr. SAS Programmer:

Responsibilities:

Worked as Statistical programmer for in various phases (II through III) of Clinical trial data

Developed and implemented SAS programs and several study specific macros, to produce descriptive statistics, statistical analyses, and graphics.

Created Analysis Datasets from SDTM as per specifications and mock shells.

Writing, testing, running, documentation and maintenance of SAS programs and macros to generate SAS datasets, spreadsheets, data listing, tables, and graphical displays of clinical trials data.

Involved in creating Adam datasets, Listings, Edit Checks and Safety tables (Summary of Demographics, Exposure, Adverse Events, Concomitant Medications Change from baseline tables, Lab-Shift tables etc.).

Reviewed case report forms (CRF) to ensure their design meets the protocol criteria and contains all data required to support a high quality database and the planned analysis.

Generated ISS and ISE reports for onward submission to FDA.

Installed, configured and maintained several instances of SAS/EBI platform and SAS/SPDS server.

Developed and participated in programming and validation efforts.

Took part in data review and performed other non-statistical ad hoc requests, QA edit checks, including review of data for adherence to protocol.

Worked closely with Biostatisticians to support the analysis of Clinical studies in various phases (I through IV).

Worked on the requests of FDA whenever required.

Worked on Adhoc’s depending on the requirements of biostatisticians and clients.

Geetanjali Group, Mumbai, India Mar2013-Jul2014

Sr. SAS Programmer:

Responsibilities:

Created various SDTM and ADAM compliance datasets in accordance with the specifications and IGs.

Developed and Validated SAS programs and macro codes to produce analysis datasets and reports including non-standard ad-hoc requests.

Experience in creating various safety and efficacy tables.

Performed edit checks on SDTM data in support to the data management team.

Reviewed SAP (containing TLF shells) and developed dataset specifications.

Created SDTM annotated CRF.

Performed validations of datasets, tables, listings and graphs.

Involved in creation of edit checks as per specifications in the process of data cleaning.

Participated in review meetings on code testing, validation and documentation standards.

Lotus Labs, Bengaluru, INDIA Mar2012 -Feb2013

SAS Programmer:

Responsibilities:

Created analysis data sets as per SAP and Spec.

Created Tables, listings and figures.

Involved in QC of analysis data sets, tables, listings and figures.

Created appropriate platform for generating analysis datasets by developing data specifications.

Performed statistical data analysis using various SAS procedures such as PROC SORT, PROC FREQ, PROC SUMMARY, PROC PRINT, PROC MEANS, etc.

Assisted in data cleaning and validation. Tested and debugged macros. Involved in the documentation process.

Created Tables, Listings and Figures.

Produced customized report as per the instructions from the Team Lead.

Generated listings, tables and graphs using PROC MEANS, TABULATE, REPORT and SAS/GRAPH.

Technical skills:

SAS Tools:

SAS/BASE, SAS/GRAPH, SAS MACROS, SAS V8/V9

SAS/ODS, SAS/REPORT, SAS/ACCESS, SAS/STAT.

SAS Procs:

Print, Means, SQL, Report, datasets, contents

Freq, Sort, Summary, Format, Import, Export, Transpose,

Compare, G-plot, Correlation, Regression.

Operating Systems:

Server2007/03/98/2000/Vista.

Office Tools:

MS-OFFICE, FrontPage, Adobe Dreamweaver

Educational Background:

MS in Electrical engineering from Texas A & M University, TX.

BS in Electrical at Jawaharlal Nehru Technological University, Kakinada, India

Contact this candidate