Jay Reddy

Clinical SAS Consultant

Mobile: 732-***-**** EXT 778

Email:

PROFESSIONAL SUMMARY:

6+ years of SAS programming experience in US clinical Research and Analysis, Design,

Development, Testing and Implementation of Clinical Trial projects And biological research.

Extensive knowledge of all four phases of Clinical Trials in various Therapeutic areas.

Excellent analytical and problem solving skills combined with the ability to work independently and in a

team.

Experience in design, programming and validation of CDISC SDTM domains.

Strong experience in various SAS procedures like Proc Print, import, Freq, Means, Sort, Univariate,

Contents, Chart, Print, Plot, Format, Transpose, SQL; and Data _NULL_ in generating reports,

tables, listings, graphs and value added datasets.

Proficient in writing macros to create SAS data sets, tables, report and graphs from Procedure Output

and automatically send to various destinations (including HTML, RTF, PDF, Printer, and Listing) by using

SAS ODS statement, as well as convert various file types to SAS Datasets.

Experienced in working closely with Data Managers and Statisticians to provide SA programming in

analyzing Clinical Trials, Clinical Data Analysis, Clinical Data Migration to generate Statistical

Analysis Files, Tables, listings, graphs, validations and Documentations.

Developed programs to produce Safety and Efficacy reports and data listings . Supported compiling

explanatory statistics, created detailed reports and graphs for FDA submission. Extensive knowledge

of Code of Federal Regulations (21 CFR part 11)

Familiar with Good clinical practice (GCP) guidelines provided by the ICH

Good knowledge of new drug & device release process from IND submission to getting approved

from FDA.

Experience in SDLC process, methodologies, and phases which includes requirement analysis, design,

implementation, verification and maintenance.

Excellent analytical and problem solving skills. Good communication and presentation skills.

Ability to work on multiple tasks simultaneously and meet project deadlines, and able work in irregular

hour.

Basic knowledge on Oracle and Teradata Database.

A quick learner and hard worker.

TECHNICAL SKILLS

Application MS Excel, MS-Word, MS-PowerPoint, MS-Project.

SAS tools Base SAS, SAS/SQL, SAS/STAT, SAS/MACRO, SAS/GRAPH

RDBMS SQL Server 2000/7.0/6.5

Operating System Windows 98, Windows 2000, Windows XP, Windows Vista,

Windows 7,

PROFESSIONAL PROFILE :

Gilead Pharmaceuticals, Foster City, CA April 2010 - Present

SAS Programmer

Roles and Responsibilities:

Jay Reddy

Clinical SAS Consultant

Mobile: 732-***-**** EXT 778

Email:

• Worked extensively in simultaneous protocols in Phase II and Phase III of clinical Trials in HIV/AIDS,

Hepatitis C and Bronchitis

• Maintained CDISC SDTM and ADaM model Standards.

• Extensively used SAS/MACROS to create complex generic macros to standardize algorithm to create

tables, listings, graphs and value added datasets.

• Used various PROC procedures such as FREQ, MEANS, GLM, GPLOT, TRANSPOSE, SORT,

UNIVARIATE, SQL etc. and delimiters and arrays as well as Data _NULL_ to generate reports,

tables, listings, graphs and value added datasets according to the Statistical Analysis Plan (SAP)

for various efficacy and safety endpoints.

• Extensively worked on SAS/ODS to create output in PDF/EXCEL/RTF format.

• Performed data validation using edit checks on the clinical trial data. Designed flowcharts indicating the

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

• Worked with time, concentration and clinical pharmacology data and was involved in PK/PD data

scrubbing (removing invalid, out-of-range, missing or duplicate values), validation, data structuring and

data integration.

• Experience in PK/PD analysis by performing parameters like, Aucmax, halflife, cmax tmax, volume,

Aucratio, etc.

• Generated Ad-Hoc reports for analyses datasets and summary reports and listings in very critically

limited time periods.

• Worked closely with Statisticians, SMEs and data managers as well as other team members to come

up with Lots, Shells and mock tables and listings from the SAP (Statistical Analysis Plan).

Environment: SAS 8.0/ SAS 9.0, SAS/MACROS, SAS/SQL, SAS/Graph, SQL, SAS/STAT, MS Office, UNIX

and Windows XP.

Super Gen, Inc. Dublin, CA Nov 2008 – March 2010

SASProgrammer

SuperGen is an emerging pharmaceutical company whose mission is to prolong, improve the quality of, and

ultimately save the lives of those people afflicted with life-threatening diseases, especially cancer. The area of

study at SuperGen is mostly oncology . The prime area of study of my project was also related to cancer. The

area of the study was the application of polymeric base drugs to act on the target sites of the tumor.

Roles and Responsibilities:

• Worked on Oncology Phase I-III studies on PIM Kinase Inhibitor drug.

• Extensively involved in extracting raw datasets from ORACLE and manipulating raw datasets to create

new variables based on SAP (Statistical Analysis Plan) by performing complex manipulations by using

Set, Merge, Sort, formats, functions and conditional statements

• Created complex and reusable macros. Extensively used, modified, tested and debugged existing

macros

• Produced data listings, summary tables, graphs and charts for final analyses using different

statements/functions/procedures for data manipulation.

• Used Edit Checks to validate for completeness, correctness and consistency.

• Developed Safety and Efficacy Listings and Tables for the clinical studies.

• Created Ad-hoc Reports for analysis data set by using Proc Reports and SAS ODS

• Used statistical procedures extensively such as Proc Univariate, Summary, Means, Freq, GLM.

• Used Proc Contents, Transpose, Sort, Print, and SQL procedures to manipulate and clean data..

• Maintained CDISC SDTM and AdaM model Standards.

Jay Reddy

Clinical SAS Consultant

Mobile: 732-***-**** EXT 778

Email:

• Reviewed project study protocols, statistical analysis plans, case report form designs, database and

analysis dataset specifications, clinical study reports and analyses submitted to regulatory agencies.

Environment: SAS 8.0/ SAS 9, SAS/MACROS, SAS/SQL, SAS/Graph, SQL, SAS/STAT, MS Office, UNIX and

Windows XP.

Ligand Pharmaceuticals, LaJolla, CA July 2007 –Oct 2008

SAS Programmer

Ligand Pharmaceuticals is a pharmaceutical company involved in the development of therapies that address the

unmet medical needs of patients for a broad spectrum of diseases including hepatitis, Alzheimer's disease,

oncology, diabetes, anemia, COPD, asthma, rheumatoid arthritis and osteoporosis.

Roles and Responsibilities:

.

• Worked on Phase II studies in Oncology on CDK (Cyclin-dependant kinase) inhibitor known as

dinaciclib (collaboration with Merck) for the treatment of various cancers.

• Generated Efficacy and Safety tables (Adverse Events, Patient profile, Demographic, Vital Signs,

Lab Descriptive, and end points from the study).

• Experience in validating the code and reports written and produced by other programmers. Also worked

on writing, editing, validating and debugging code in BASE SAS & MACROS.

• Extensively worked on various ad-hoc and interim analyses reporting; as per

guidelines and requests using PROC REPORT, PROC PRINT, DATA, _NULL_ and PROC FORMAT.

• Produced basic statistical analyses using procedures like PROC MEANS, PROC FREQ, PROC

UNIVARIATE, PROC SQL, and PROC TRANSPOSE

• Interacted closely with the SME’s, Statisticians and study specific Manager

• Created PDF/RTF files using SAS ODS for clinical trial reports and for submissions to FDA.

• Created reports in different formats like RTF, PDF and HTML using SAS output delivery system

(ODS).

• Used PROC SQL, FREQ and MEANS for data analysis and generating report using TABULATE and

REPORT.

• Worked with different clinical trials data like Demographics, Adverse Event (AE), Serious Adverse

Event (SAE), Laboratory and Physical Examination.

• Performed Data Validation and Data Cleaning on Clinical data using procedures like Proc Freq, Proc

compare and departmental macros.

• Modified existing data sets by using the statements like SET, MERGE, UPDATE and Conditional

statements.

• Analyzed descriptive statistics using various Proc Means, Proc Freq, Proc Summary, Proc SQL and

Proc Univariate.

Environment: SAS 8.0/ SAS 9, SAS/MACROS, SAS/SQL, SAS/Graph, SQL, SAS/STAT, MS Office,

UNIX and Windows XP.

Valeant Pharmaceuticals, Fort Worth TX May 2006 – June 2007

SAS Programmer

Valeant Pharmaceuticals is involved in the discovery, development, and commercialization of products primarily

focused in infectious diseases, neurology, and dermatology.

Roles and Responsibilities:

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

II.

Jay Reddy

Clinical SAS Consultant

Mobile: 732-***-**** EXT 778

Email:

• 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. 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.

• 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.

• Performed Data Cleaning, Data Validation according to the requirement of Clinical and Data

Management Department (DMD).

Environment: SAS/Base, SAS/SQL, SAS/Access, SAS/Macro, Windows 2000 server, Microsoft PowerPoint

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