Gaurav Desai

Email: ac4jae@r.postjobfree.com

Phone: 732-***-****

SUMMARY:

Over Nine years of experience in SAS programming with good knowledge of advanced statistical methodologies applied in Pharmaceutical and Biotech industries.

Expertise in analyzing and reporting various phases (Phase I-IV) Of Clinical Trials using tools like Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS and SAS/ODSin UNIX and Windows environment.

Working knowledge of General linear models, Categorical data analysis, Survival analysis, Multivariate analysis, Design of experiments, longitudinal data analysis, randomized trial designs and survey design and analysis.

Experience in providing statistical support for clinical studies, including design of studies, selection of appropriate statistical methodologies and tests, sample size and power calculations, randomization, statistical analyses, and interpretation of results.

Experience in debugging and testing SAS programs to check and process data, generate graphs, tables and listings in analysis system.

Individually capable of developing new SAS Programs and/or enhancing existing SAS programs from protocols and SAP’s.

Experience in Data manipulation and producing reports employing various SAS procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, and PROC CONTENTS.

Hands on experience in SAS programming for importing and exporting huge data sets from Flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.

Hands on experience in Oracle, PL/SQL programming to create Triggers, database Packages Procedures/Functions. Creation of database objects like Tables, Views, and Synonyms etc.

Extensive use of SAS/ACCESS, SAS/CONNECT to connect to various databases such as development and production database (DB2 on UNIX).

Experience in reviewing case report forms CRF’s/SDTM/ADaM to ensure that the protocol objectives are met and the project standards are maintained.

Working knowledge of medical terminology in clinical trials, clinical trial methodologies, and software systems development.

Exposure to CDISC Standards, 21 CFR Part 11, GxP guidelines, Bioethics, IRB guidelines, HIPAA guidelines and Regulatory Submissions (CSR, BLA, NDA, including ISE and ISS).

Efficient in maintaining working relationships with clients and internal project members, including data managers, research scientists, and other statistical programmers.

Experience in developing and maintaining statistical documentation, including description of statistical methods, SAS programs, results and discussion.

Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.

Possess a strong ability to adapt and learn new technologies and new business lines rapidly.

Effective team player with strong communication & interpersonal skills.

SKILL SET:

Operating systems : UNIX, WINDOWS XP/2000/98

Web Technologies : HTML, Adobe Dream Weaver

SAS Tools : SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Access, SAS/ODS, SAS/Report

Database : Oracle Clinical, SQL Server 2000, PL/SQL and MS Access

MS Office : Word, Excel, PowerPoint, Access and Outlook

Statistical tools : SAS v 9.x/8.x/6.x, SPSS, R/S-Plus

PROFESSIONAL EXPERIENCE

Quintiles, Durham, NC Jan 2013 - present

Clinical SAS programmer

Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.

Generated Tables, Listings and provide QC check, validation of outputs for Oncology clinical trials.

Responsible for Developing reports for Safety and efficacy as per study requirements.

Involved in Developing, Debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.

Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.

Performed QC (Quality Check) extensively on tasks performed by other team members and involved in data validation and data cleaning in all phases of Clinical studies.

Extensively used Proc SQL to retrieve, update and report on information from SAS data sets and other database products.

Modification of existing SAS programs and creation of new programs using SAS Macros.

Built Macros and create macro variables using %LET, CALL SYMPUT, and DATA _NULL_ to help generate analysis data sets and create specified structure of TLFs.

Ability to quickly debug SAS compiling errors, to review SAS code and quickly identify areas of concern.

Worked with Statisticians and Clinical Data Managers to provide SAS programming in analyzing the Clinical Trials and generating Reports.

Created analysis datasets based on the guidelines provided in the Data Definition Tables (DDT) and following the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.

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

Worked on multiple protocols and/or drug compounds at a time.

Environment: SAS 9.x/8.x, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, Windows NT.

Vertex., Boston, MA Aug 2011 – Dec 2012

Clinical SAS programmer

VERTEX specializes in designing customized solutions to aid the pharmaceutical, biotechnology, medical devices and diagnostics industry by establishing the safety, efficacy and value of health technologies. Primary areas of research include registries and late-phase clinical trial studies as well as market research and strategies.

Therapeutic area: Oncology/Hematology

Provided SAS Programming and analysis support for phase III (oncology) clinical trials

Co-worked with Statisticians as a primary SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.

Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).

Extracted data from ORACLE database and involved in cleaning the data (data cleansing) using various edit check techniques.

Used procedures like PROC TRANSPOSE, PROC SORT, etc in Data transformation and Manipulation processes.

Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.

Effectively developed SAS code for modeling data and implemented 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.

Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data _Null_ technique, Proc Gplot etc.

Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML

Validated analysis 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.

SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.

Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.

Majorly worked with the data management team and was involved in handling documentation and submission processes (under managers’ assistance).

Environment: Windows XP, Oracle 9i, SASV9.1.3, Base/SAS, SAS/Access, SAS/Macro, SAS/STAT

Shire, Lexington, MA Aug 2010 - June 2011

Sr. Statistical programmer

SHIRE is a biopharmaceutical company focused on discovery and development of drugs for treatment of chronic inflammatory diseases and cancer. Confidential has a diversified pipeline of drug candidates developed over the past decade with full capacity to develop products from target identification through lead optimization, preclinical development, and clinical trials.

Therapeutic area: Rheumatoid Arthritis

Provided SAS programming support to Bio-statisticians and data management team for analyzing clinical trial data and validation of tables, listings and reports.

Extracted Clinical trial data from Oracle database by using Proc SQL Pass through Facility.

Data Cleansing to remove erroneous data entered by using edit check programs before the data analysis.

Responsible to write, modify, validate and implement SAS programs according to Statistical Analysis Plan (SAP).

Produce safety summary results with tables, listings, and graphs, performing quality control of other programmers work and debug complex programming code.

Extensively used procedures like PROC SUMMARY, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC COMPARE, PROC REPORT and PROC TRANSPOSE and other statistical procedures like PROC ANOVA, PROC GLM AND PROC REG.

Generated reports using Data steps and various procedures such as Proc Sort, Proc MEANS Proc Tabulate, Proc Freq, Proc SQL, Proc Reports and Macros.

Used SAS tools like Proc SQL to perform queries, join tables, create and manage tables.

Validation of datasets and TLGs and peer reviewing of the fellow programmers’ code.

Developed and validated standard and custom data listing, datasets, summary tables, and Graphs as per requirement and standard protocols and involved in study designs.

Contributed to Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and Reports for clinical Studies.

Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.

CDISC mapping using SDTM model- created data tabulations and verified using Proc CDISC. Worked with different classes (intervention, events, findings, special purpose).

Environment: Windows XP, Oracle8.x, SASV9.1, Base/SAS, SAS/Macro, SAS/STAT, SAS/GRAPH

Prosoft Clinical, PA Aug 2008 – July 2010

Statistical programmer

PROSOFT Center for Clinical Research ("ACCR") provide leading edge health care through the diagnosis and treatment of patients suffering from rheumatologic and related disorders.

Therapeutic area: Rheumatoid Arthritis

Generated statistical analysis files, tables, listings, and graphs for Phase III drug trial studies.

Collaborated with Statisticians, Data Manager, and other SAS programmers to provide ad-hoc and routine analyses and reports with regards to the assigned projects.

Support Data management in data creation/transfers and integrity checks

Imported external files like Excel files, text files, and Database files into SAS data sets using INFILE, LIBNAME, PROC IMPORT, SAS/Macros, and SAS/Connect, etc.

Used various procedures such as Proc Means, Proc Freq and Proc Univariate to check assumptions and produce initial analyses.

Worked with different clinical trials data like Demographic, Medical History, Vital signs, Adverse Event (AE), Physical examination.

Created SAS data sets by extracting data from various sources and prepared them for statistical analysis. Manipulated data sets by using RETAIN, ARRAY, DATA _NULL_, SAS Functions, etc.

Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.

Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate.

Written custom safety and efficacy reports by directing SAS output to RTF and HTML files using SAS/ODS.

Ensured analysis data and programming code meet regulatory and company standards (FDA and ICH regulations) and are consistently structured to permit efficient programming and reporting.

Cross-validated programs with others: compared outputs and proofread the coding.

Environment: Windows NT, SASV8.2, Base/SAS, SAS/Access, SAS/Macro, SAS/Connect, SAS/STAT

Eisai, NJ Jan 2006 – June 2008

Statistical programmer

EISAI is a technology based and knowledge driven enterprise, offering integrated services in Biotechnology and Pharmaceuticals. It offers Clinical Developmental Services in areas such as Bioequivalence, Clinical trials related activities, Data Management and Biostatistics Operations.

Data manipulation on SAS data sets using techniques such as merging, appending, concatenating and sorting.

Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option.

Responsible for initial exploratory analyses, checking assumptions for required tests.

Produced outputs in different formats such as HTML and PDF and using SAS/ODS.

Environment: SAS/BASE, SAS/STAT, WINDOWS and MS EXCEL

EDUCATION:

Masters of Science in Statistics, VILLANOVA UNIVERSITY, GRADUATE LIBERAL ARTS AND SCIENCES University

Courses in Design of Experiments and regression, Clinical trials, SAS programming for statisticians, Categorical Data Analysis, Perspective in Advanced Biostatistics

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