Data Sas

DEEPTHI CHOWDARY

Sr. SAS Programmer Ph: 718-***-****

PROFESSIONAL SUMMARY

• Professional SAS Programmer with7+ years of experience in using SAS for Data Management and Reporting in

the Pharmaceutical and Clinical research industries.

• Good knowledge of drug development processand clinical trial phases (Phase I, II, III) and their designs including

open-labeled, single blinded, double blinded, randomized and crossover studies.

• Good experience in Clinical Data Analysis, derived datasets, creating tables, generating listings, reports and graphs.

• Good experienceinBase SAS, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/STAT, SAS/ODS and SAS/GRAPH.

• Experience in preparation of SAS Datasets, Tables, Listings, Graphs, Output Delivery System ( ODS) and Summaries

according to requirements, Standard Operating Procedures ( SOPs), Statistical Analysis Plan (SAP).

• Experience in validating SAS Datasets, Tables, Listing and Figures using Proc Compare Procedure.

• Experience in cleaning and resolving data issues as well as merging data from different sources into a single

integrated dataset.

• Experience in Data Manipulation procedures like SAS Formats / Informats, Merge, Proc Append, Proc Datasets,

Proc Sort andProc Transpose.

• Expertise in transforming data imported from disparate data sources into analysis data structures, using SAS

functions, options, ODS, array processing, macro facility, and storing and managing data in SAS data files.

• Good knowledge of Clinical Terminology and Regulatory Guidelines. Good understanding of regulatory

requirements,NDA processes, from IND submission to FDA approval (in compliance with 21CFR Part 11). This

includes Clinical Trials (Phases I-III), preparation of IND, NDA, safety reviews, adverse event report reviews and

production of integrated safety and efficacy summary (ISS & ISE) for FDA submission.

• Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data

Tabulation Model) standards.

• Proficient in understanding of Study Protocols, SAP (Statistical Analysis Plan), and CRFs.

• Performed Data management like Merging, concatenating, interleaving of SAS datasets using MERGE and SET

statements in DATA step and PROC SQL.

• Experienced in Base SAS procedures such as PROC FREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT,

REPORT, TABULATE, TRANSPOSE, DATASETS, COPY, PRINT and SQL.

• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Vitals, Laboratory Data.

• Producing data in various output formats including HTML, RTF, PDF using ODS (Output Delivery System).

• 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.

• Experienced in working closely with statisticians to provide SAS programming in analyzing Clinical Trials data and

generating Statistical Analysis Files, Tables, Listings, Summaries, and Graphs.

• Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of Clinical Trials.

• Experience in producing external files and reports employing various SAS statements and procedures, ODS, Proc

Report, Proc Tabulate in Clinical Trials.

• Experience in giving guidance to team as and when required.

• Adaptability and ability and to understand job requirements, new methods, ideas, concepts, and technologies.

TECHNICAL SKILLS

SAS Tools : SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/SQL, SAS/REPORTS, SAS/STAT,

SAS/MACROS, SAS/ODS and SAS/GRAPH

SAS Process : Print, Means, Tabulate, Univariate, SQL, Report, Freq, Sort, Summary, Format, Import,

Export, Transpose, Compare, Gplot and Gchart.

Languages : C, SQL, PL/SQL, HTML and XML

Databases : MS Access, SQL Server and Oracle

Business Tools : Microsoft Word, Microsoft Excel, Microsoft PowerPoint.

Operating Systems : Windows, LINUX

EDUCATION

• Bachelor of Pharmaceutical Sciences.

PROFESSIONAL EXPERIENCE

Novartis Pharmaceuticals, East Hanover, NJ Jul 2012–Present

Clinical SAS Programmer/Consultant

Novartis Pharmaceuticals is a globally known company where research studies are intended to answer scientific

questions and find better ways to treat or prevent diseases. This position involved creating tables, listing and analysis

datasets for phase III Clinical Trials as per the standard specifications besides data cleaning, annotating CRF, and quality

control as per company’s standards.

Responsibilities

• Involved in managing randomized phase II and III Clinical Trials data.

• Developed new and modified existing SAS programs to load data from the external source and create study specific

datasets, which are used as source datasets for report generating programs.

• Modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.

• Developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation.

• Created and validated Tables, Figures, and Listings according to the Statistical Analysis Plan (SAP)

• Created SAS Macros and modified the existing ones relating to multiple studies.

• Used SAS/ODS for generating different output formats as requested.

• Extracted data from Oracle using SQL Pass through facility and generated ad-hoc reports.

• Generated tables and listings based on CDISC SDTM standard.

• Involved in generating Safety tables (ISS) as per the requirements of the Statistician and SAP.

• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as

appropriate. Reviewed and provided feedback for Data Integrity Plans.

Environment

SASBASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, SAS/SQL and Windows.

Quintiles, Overland Park, KS Jun 2011–May2012

SAS Programmer

Quintiles is a contract research company providing a wide range of clinical research services for biotech and

pharmaceutical clients all over the world. This project involves in Phase I to Phase III Clinical Trials for oral cancer

treatment. Collaborated with Biostatisticians and representatives from clinical to regulatory to develop clinical trial

reporting systems, tables, patient listings, case report form tabulations and derived datasets.

Responsibilities

• Worked with Biostatisticians and data management on clinical studies.

• Programmed statistical summary tables, graphs, and patient data listings using base SAS procedures such as PROC

SUMMARY, PROC TABULATE.

• Extracted data from the clinical trial databases and created SAS statistical analysis files for regulatory submission.

• Extensive use of SAS/BASE and SAS/STAT for producing tables, listings, figures, and generating statistical reports.

• Used Output Delivery System (ODS) facility to write custom safety and efficacy reports directing SAS output to RTF

and HTML files.

• Developed routine SAS MACROs to create tables, graphs, and listings for inclusion in clinical study reports, and

regulatory submissions and maintained existing ones.

• Generated Linear and Non-Linear Graphs using SAS/Graph.

• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical Trials.

• Involved in the reviewing of SAP, Prepared and documented programming specification.

• Used SAS/Base & SAS/Macro to write data extraction programs to extract data, Create data sets, to clean data.

• Done stacking and merging of various datasets.

• Involved in validation of datasets using Proc Compare.

• Extensively used SAS procedures Print, Report, Sort, SQL, Mean, Freq etc. to analyze data and produce reports.

Environment

Base SAS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, MS EXCEL, Oracle 8, HTML

Bristol-Myers Squibb, New Jersey Jul 2010 – May 2011

SAS Analyst

Bristol-Myers Squibb is a global BioPharma company firmly focused on various therapeutic areas. Project focused on

analyzing the data HGB data, with a comparative study of effects of therapeutic drug in Cervical, Prostate and Colorectal

cancer patients. Participated in phase II and III Clinical Trials.

Responsibilities

• Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.

• Designed and implemented statistical reporting processes for clinical data analysis.

• Analyzed Phase I, II and III Clinical Trials.

• Transformation & Loading, change the data capture. Involved in writing of clinical trial reports (phase I-III), analyzing

and presenting trial results.

• Performed Data analysis, statistical analysis, generated reports, listings and graphs using various SAS Tools like

SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect, SAS/Access.

• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time and created

tables,listing reports.

• Created SAS Customized Reports using the Data _Null_ technique for FDA evaluations.

• Performed Validation and QC of datasets, tables, listing and graphs.

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

• Used PROC SUMMARY, PROC MEANS, PROC TABULATE for report generation.

• Assisted in validation, edit checks and data review listing.

• Created Summary Reports and tabular reports using Proc Report.

Environment

Base SAS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, MS EXCEL, Oracle 8, HTML .

Bayer Pharmaceuticals, RTP, NC Jan 2009– Jun 2010

SAS Programmer/Analyst

Bayer Pharmaceuticals is a biopharmaceutical company engaged in the discovery and commercialization of new

therapeutics that treat serious and life-threatening diseases. Data analysis was tested for the cardiovascular therapeutic

area. It involved Phase I trial to determine the Maximum Tolerated Dose (MTD) by giving dose to patients in groups. The

test was a randomized double blind method.

Responsibilities

• Produced datasets, tables, listings and summaries using SAS programming solutions from the clinical trial data.

• Created CDISC SDTM compliant datasets.

• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical Trials.

• Used SAS/MACROS to develop SAS programs.

• Assisted in SAS programming in Results validation, data validation and code validation.

• Generated codes for data manipulation, statistical analysis, data analysis, report generation using SAS MACROS.

• Used SAS data steps, procedures and functions to create analysis datasets, tabulation datasets and listing datasets

as per SAP.

• Created data presentations by producing tables, and listings using ODS, PROC REPORT, PROC FORMAT AND

DATA_NULL_.

• Identified the missing data and duplicated data in the SAS datasets.

• Extracted datasets from SAS transport format files using PROC CIMPORT procedures.

Environment

Windows, SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL

G.V.K Bio Sciences Pvt Ltd, Hyderabad, India Apr2007–

Nov2008

SAS Programmer Analyst and Junior Research Associate

GVK BIO is a contract research services to a rapidly growing base of global pharmaceutical and biotechnology

companies. It combines Science, Innovation and People to help clients address their drug development challenges. GVK

BIO is one of India’s premier CRO providing an integrated platform of research services across the Pharma R&D value

chain to a growing number of global Pharma and Biotech companies.

Responsibilities

• Wrote SAS Programs on day to day basis as per the requirements of the Manager.

• Used various different statements like Substring, Merge, and Index for data analysis.

• Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation,

including testing SAS code.

• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/

Macro facility.

• Responsible for coding, debugging, generating listings, analysis of output, reporting.

• Performed data validation on the clinical trial data.

• Developed permanent SAS formats, templates and libraries.

AurobindoPharma, Hyderabad, India Jan2006–

Mar2007

Clinical Data Analyst

This Project’s primary goal is developing new treatments and supportive care for Cancer patients. The Project focused on

analyzing the data from a comparative study of investigational adjuvant therapy with an established adjuvant therapy in

preventing the recurrence of cancer in surgically treated stage III colon cancer patients.

Responsibilities

• Involved in the analysis of Phase I and Phase II clinical data.

• Cleaning of data using Data Step and SAS Base Procedures.

• Assigned formats and labels to the variables in analysis data sets.

• Generated tables and listings according to Protocol and Statistical Analysis Plan (SAP) using PROC PRINT, PROC

REPORT and PROC TABULATE.

• Generated summary reports and descriptive statistics.

• Created and applied user defined formats to specific variables in SAS data sets.

• Responsible for data validation and corrections – uploading / downloading data.

• Writing analysis plans including specifications for Tables, Listings and Figures.

Environment: SASBASE, SAS/STAT, Windows.

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