Data Sas

Ashritha Reddy

214-***-****(m) *****************@*****.***

SUMMARY:

Over all 6+years of Experience in working with SAS 8.2/ 9.2/ 9.4 in Unix, Linux & windows Environments.

Good Knowledge of different phases (phase I to IV) of Clinical trials in various therapeutic areas like Oncology, Pulmonary, Cardiovascular and Epidemiology.

Expertise in analyzing and coordinating clinical trial data generating Tables, Listings and Graphs.

Experience in producing HTML, RTF and PDF formatted files using SAS/ODS.

Experienced in the analysis, design, and development and testing of clinical applications in the Pharmaceutical, and CRO Industries.

Experienced in SAS Macro Language.

Reviewing Clinical Study Protocol, CRF forms, and Data Analysis Plan documents.

Experience in modeling for risk rating, and performing various business analyses like Product performance, Customer behavior, and Market performance

Proficient with SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS MACROS and SQL.

Responsible for developing and modifying reports based on Statistical Analysis Plan, or creating Ad Hoc reports by using REPORT, and SUMMARY and also provided descriptive statistics using MEANS, FREQ, and UNIVARIATE.

Worked on Data Management SAS DATA step processing, PROC SQL for data extraction, write datasets, Report, generate list for phase I/III clinical trials and use of PROC REPORT, DATA NULL, SAS Macro processing.

Experience in designing star schema, Snowflake schema for Data Warehouse, ODS architecture.

Experience on creation of CDISC ADaM datasets from SDTM datasets or Legacy Datasets as per ADaM Specification (Protocol, Annotated CRF, SDTM Datasets,Statstical Analysis Plan (SAP) and Mock TLF Shells.)

Specialization in Data Modeling and experience in designing phase of Software Development Life Cycle.

Well versed with Clinical Trial processes such as Randomization Process, Trial execution, Statistical Analysis, Data capture, Data cleaning, Data Management and Reporting.

Developed tables, and figures, for clinical studies and prepared regulatory documents for FDA submissions.

Proficient in developing Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy(ISE) by combining several studies.

Collaborated with Clinical Data Management to annotate CRFs with standardized variables and formats using Proc Datasets, Proc Formats.

Experience in providing Clinical Study Reports, compliant with FDA guidelines in 21 CFR Part 11 for electronic submissions.

Working knowledge of FDA regulations, ICH Guidelines and GCP requirements.

Ability to communicate and work with persons at different levels of management and collect requirements from users.

Ability to handle multiple tasks and work independently as well as in a team.

TECHNICAL SKILLS:

Operating System : Windows 98/2000/XP, UNIX

Languages : SQL

Utilities : MS-Office

Database : Oracle, Teradata and MS-Access

Web Too : HTML

SAS Tool : SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH

SAS/ACCESS, SAS/CONNECT and ODS etc.

SAS Procedures : Import, Export, Format, Tabulate, Report, Summary, Sort, Print,

Contents,Append,Copy,Rank,Freq,Means,Reg,Corr,GLM, Anova,Univariate, Ttest, Transpose, Gplot, Gchart, Cport, Cimport, Datasets,

Compare etc…

Experience in SAS Enterprise Guide, SAS ETL

EDUCATION:

Bachelors in Electronics& Communication Engineering, JNTU, 2010.

Master in computer science, 2016.

EXPERIENCE:

Boston Scientific, IL April 2016- Till date

Position: Clinical SAS Programmer

Therapeutic Area: Oncology, Respiratory studies

Boston Scientific is a pharmaceutical company. Worked on clinical trial safety and efficacy data which is a phase II Double blind, Double dummy DSMB study. Followed CDISC SDTM standards and Prepared SDTM and ADaM datasets. Generated Summaries and listings as well.

Responsibilities:

Created and maintained SAS Datasets extracted from Database.

Worked with different clinical trials data, Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory, and Physical examination.

Produced analysis datasets for generating Reports.

Created Tables, Listings, Graphs and customized reports using various procedures PROC Report, PROC Tabulate, Data _null _ and PROCGPLOT.

Involved in creation of CRT datasets transport files and associating documentation as a part of FDA submissions

Involved in writing the SAS code to help in the process of Quality control by implementing various statistical procedures PROCFREQ, PROCMEANS, PROCUNIVARIATE and PROCSUMMARY, PROC Transpose, PROC SQL and PROCPRINT.

Wrote SQL Queries to debug duplicate values and missing values.

Used the SAS Macro facility to modify existing departmental macros and to replace repetitive codes.

Extensively used SET, MERGE, UPDATE statements and PROC SQL for adding new variables or observations, creating subsets or modifying datasets.

Produced quality customized and ad hoc reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC MEANS, FREQ.

Produced RTF, PDF and HTML formatted files using SAS/ODS.

Documented data sets using specifications worked out in conjunction with senior manager.

As a clinical data associate performed UAT on EDC Software and reported the edit checks.

Performed Quality Control, Data Validation and Edit Checks using various Procedures and Macro facility.

Wrote SAS Programs for the edit checks that were detected manually.

Performed validation of SAS-generated output (tables, listings and graphs) via independent programming. Also performed QC checking and validation of SAS programs written by other programmers.

Participated in team meetings to discuss best programming practices. Established and maintained sound working relationship and effective communications within Biostatistics, Statistical Reporting, and the Data Management group.

Environment: SAS v9.1, SAS/BASE, SAS/GRAPH, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/ACCESS

Kaiser, Pleasanton, CA Nov 2015- Mar 2016

SAS Programmer

The scope of the project is to implement marketing strategy, evaluate performance and to validate initial program assumptions, analyze time – trended data to improve performance forecasting of future programs.

Responsibilities:

• Created new and modified existing SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.

• Extracted raw data from the warehouse and created SAS data sets that are required for the project analysis using SAS/ACCESS and SAS/CONNECT.

• Developed several ad hoc SAS programs to create summaries and listings.

• Customize the existing programs using SAS Macros as per the statistician's requirements

• Analyzed different drugs sales activity metrics and generated reports and graphical representation of these sales for comparison of different drugs using SAS/GRAPH and SAS/STAT. Used PROC GPLOT to create graphs in SAS.

• Experience in Clinical Data Analysis, Generating Statistical Analysis Files, Lists, Tables, Graphs, Validations, Documentation, FDA Electronic Submissions. Good Experience in Phase I, II, & III Clinical Drug Trials studies.

• Understanding of drug development process - conducting clinical trials, collection (paper CRF, eCRF (EDC, RDC)), analyses and presentation of data

• Generated SAS Customized reports using the DATA _NULL _ and PROC REPORT techniques.

• Involved in pooling of data from multiple studies and generating Tables/Listings/Graphs for Summary of Clinical Safety (SCS) for FDA Submission.

• Understanding of Bio-statistical work flow: Starting from Raw Datasets to creation of submission package i.e., CRT packages.

• Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines.

• Excellent experience in Parallel and Cross-Over (esp. Phase I) study designs.

• Developed SDTM data mapping and created SDTM datasets per CDISC standards.

• Created TEMPLATES to modify the appearance of the displayed ODS tables using PROC TEMPLATE.

• Extensively used PROC FREQ, PROC TABULATE, PROC MEANS, PROC MACROS, PROC SUMMARY, PROC CONTENTS, PROC COMPARE and PROC UNIVARIATE.

• Performed data analysis on the data sets using PROC MEANS, PROC FREQ, and PROC UNIVARIATE etc.

• Developed summary reports using SAS PROCEDURES like PROC FREQ, PROC UNIVARIATE, PROC SUMMARY, PROC REPORT, PROC MEANS, and PROC TABULATE etc.

• Developed custom reports using Data _Null_

• Gave significant contribution in modifying or rewriting an entire report section using SAS MACRO, SAS/FUNCTIONS, PROC CONTENT, PROC MEANS, PROC FREQ, PROC TABULATE, PROC REPORT, etc. according to Oracle database format.

• Used ODS statements and PROC TEMPLATE to create reports in style format.

• Used SAS extensively to create ad hoc reports.

• Used SAS Macros, PROC SQL to extract, sort, match test accounts and ODS to HTML, PDF and RTF

Environment: SAS/Base, SAS/STAT, Teradata, SAS/SQL, SAS 9.1.3, Windows XP Professional, SAS/Macro, SAS/Access, SAS/STAT, SAS ODS, SAS/GRAPH, SAS/IML, SAS/ ETL, SAS BI, Oracle 10g, Teradata, SAS V9.1.3, SAS Views, SAS Enterprise Guide, SAS/DI studio 4.2, Management console, SAS/information mapping, Excel, Windows XP, UNIX.

HDFC Bank, India Sep 2012 – July 2015

SAS Programmer

HDFC Bank is the leading bank company in India. Responsible for acquisition modeling in the emerging markets of India. As it was not easy to buy geographical and demographic data In India, customer data was built internally by gathering demographics and general information of card members pertaining to diverse products to extract information about solicited and non-solicited responders over a period of time. Compared and analyzed trend and related information from this data to create customer SAS datasets and flat file for modelers. These datasets were used for capturing new customers through direct mail and telemarketing

Responsibilities:

Created SAS datasets from Oracle database with random sampling technique and created Oracle tables from SAS datasets by using SAS Macros

Created large datasets by combining individual datasets using various inner and outer joins in SAS/SQL and dataset merging techniques of SAS/BASE

Analyzed data using various statistical PROCEDURES like PROC SUMMARY, PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC REG and PROC ANOVA

Used SAS/Macro facility to create macros for statistical analysis, reporting results and data extraction

Proposed a set of action plans to mitigate the risks identified with the sourcing decision

Generated HTML, Listings, EXCEL and RTF reports for presenting findings of various statistical PROCEDURES using PROCEDURES like PROC REPORT, PROC PRINT, PROC FREQ and also SAS ODS

Environment: SAS/BASE 8.2, SAS/ACCESS, SAS/GRAPH, SAS/MACRO, SAS/ODS, SAS/SQL, SAS/STAT, SQL, ORACLE

Andronovo Labs, India May 2010- August 2012

Position: SAS Programmer-Intern

Responsibilities:

Trained in various data management skills like Merging, Handling missing values, Reading raw data files, Creating data structures, Handling programming errors, Accessing and Managing data, Appending, Concatenating, and Interleaving of SAS datasets.

Has been trained on SAS/ODS procedures. Expertise with SAS/BASE, SAS/MACRO, SAS/SQL, AND SAS/ODS (RTF, PDF, EXCEL, XML) procedures.

Well trained in importing and exporting EXCEL and ACCESS files using LIBNAME, PROC IMPORT, PROC SQL, PROC EXPORT.

Broadly used SAS/MACRO for creating macro variables, macro programs and Autocall macro library to modify existing SAS program for ease of modification while maintaining consistency of results.

Comprehensively prepared reports using SAS report generating procedures like PROC PRINT, PROC FREQ, PROC MEANS, PROC TRANSPOSE and PROC SQL.

Well versed with using data _null_, SAS formats, informats and functions, data manipulation & report.

Considerably experience in Data Merging, Data Subsetting with the use of PROC SQL, MERGE and SET statements.

Trained on SAS/SQL for Creating summary reports, Displaying query results, Generating Tables and Views, SQL joins and Set operators.

Completed Training of Generating Reports using SAS/Reports, generating procedures like PROC PRINT, PROC FREQ, PROC MEANS and PROC TRANSPOSE.

Environment: SAS/BASE 8.2, SAS/ACCESS, SAS/GRAPH, SAS/MACRO, SAS/ODS, SAS/SQL, SAS/STAT, SQL, ORACLE

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