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UMA D BHOGA

Clinical SAS Programmer

ac03qb@r.postjobfree.com

Ph No: 510- 480-7107

• SAS programmer with 2 years of experience in Clinical Data

• Worked on different databases like WINDOWS, SAS Studio, Enterprise Guide, SQL Server, introductory experience to EDC tool on Oracle Clinical Simple forms, Rave

• Knowledge of the Drug Development Process in phase I, II and III of clinical trial data

• Good knowledge on ICH, NDA, IND and FDA-21 CFR part 11and GCP regulations, cGMP, and guidelines

• Commanding Domain knowledge in CDISC, SDTMIG, SDTM, ADaMig, ADaM models

• Experienced in using various SAS modules such as SAS/BASE, SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/MACROS, SAS/ACCESS, SQL, Oracle.

• Extensively used SAS Procedures and Functions to produce Tables, Listings, Graphs (TLGs)

• Hands on experience in various SAS procedures like PROC COMPARE, PROC FREQ, PROC MEANS, PROC SORT, PROC SQL, PROC REPORT, PROC FORMAT, PROC TABULATE, PROC COPY, PROC TRANSPOSE, PROC UNIVARIATE, PROC ANOVA, PROC SUMMARY, PROC APPEND and PROC DATASET etc.

• Commanding experience in High Resolution Graphs/Plots

• Experience on CRF Annotations, Edit checks.

• Extensively used SAS/ODS procedures to generate Reports

• Extensive experience in creating SDTM using SDTMIG and Analysis Datasets using SAP and CDISC Standards

• Knowledge in generating Clinical Study Report (CSR) and integrated summary of Safety

(ISS) and Efficacy (ISE) for NDA submissions using SAS along with senior SS programmers.

• Reviewed SAP, Protocol and annotated CRF, Mock shells and Clinical Trials Standard Dictionaries such as MEDRA and WHODRUG

• Performed Edit check programming to identify potential data issues and conducted data validations as per data dictionary guidelines.

• Used SAS Macros extensively in the creation of new programs as well as the modification of existing programs to improve ease and consistency of results

• Highly self-motivated and goal-oriented professional under minimal supervision in a team environment

• An excellent problem-solver, able to quickly grasp complex systems and identify opportunities for improvements and resolution of critical issues. 2

SOFTWARE SKILLS

SAS Products Base SAS, SAS/MACRO, SAS/ODS, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/STAT, JMP, Enterprise Guide, SAS studio SAS Procs Proc Print, Proc Datasets, Proc Format, Proc Sort, Proc Means, Proc Report,

Proc SQL, Proc Freq, Proc Sort, Proc Append, Proc Transpose, Proc Compare,

Proc Univariate, Proc Summary, Proc Tabulate, Proc Gplot, Proc Gchart, Proc Proc Copy

Proc GLM, Proc ANOVA, Proc Mixed, Proc TTEST, Proc Lifetest etc Languages & Tools SQL, PL/SQL, C, C++, MS-Office

Databases EDC tool on Oracle Clinical, Rave,MS Access, Sci-Finder, Chemdraw, MDL Search MS- Word, Excel, Power point

OS Unix, Windows XP/NT/2000, Enterprise Guide, SAS Sudio Datasets Raw datasets, SDTM, Analysis datasets

Professional Experience:

inVentiv Health, Boston, MA Jan’15-Dec’16

Responsibilities:

• Extract data from various databases using Libname statements, %include stmts

• Reviewing raw data using Proc contents to determine the SDTM Compliance

• Protol driven CRF booklet review for each subject, edit check the CRF, addressing any issues wrt data consistency, integrity, quality, accuracy, CRF pages

• CRF specified Formats for categorical data, continuous data

• SDTM end-to-end mapping of the raw datasets using SDTMIG v3.1, 3.2 and ADaM datasets creation from SDTM datasets using SAS programming

• Generation and archiving of Excel files, PDF files, RTF files, MDB files, Text files using ODS, Proc Print

• Develop Data Definition documentation at TOC level, Dataset level, Variable level, Value level, Algorithms

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• Xpt file generation using Libname stmt and Proc copy

• Pinnacle 21 Validation using drag and drop of Xpt files, reviewing Dataset Summary, Issue Summary, Detail Summary, Rules and address the issues by SAS programming

• Specification Development from Rawdata and SDTM mapped data on Excel spread sheet

• Updating Issue log with modification history and date of modifications, person Modified, topic of modification

• Generation of ADaM datasets from SDTM datasets and Supplemental datasets by merges, sql joins. Initially ADSL by merging SDTM.DM, SUPP.DM and Vitals for height/weight. ADaM BDS datasets creation by joining ADSL and SDTM datasets

• Review and edit check of SAP, Mock shells for consistency, integrity before generating Analysis datasets and looking for traceability wrt CRF

• Derivations of Age, Dates, Durations, Study day, CHG, PCHG, BMI, height, weight, flag variables based on SAP specifications

• Extract non missing and conditionally subset the ADaM datasets with required variables specified in Mock shells and SAP, Sort by common variables, merge/join by common variables to create Analysis datasets

• Analysis datasets one-step away from analysis

• ODS, Proc Report for Listings to dump the data

• Generate Summary statistics of Continuous variables using Proc Means procedure for Tables

• Generate Summary statistics for Categorical variables using Prof Freq procedure for one way or N-Way Tables

• Finally, Proc Transpose to create required format of tables

• Generation of Safety tables on Demographics, ITT, Saffl, Adverse Events by Severity, Relatedness, TEAE, SOC/PT along with Senior SAS programmers

• Develop programs using SAS (Statistical Analysis Software) and SQL

• Validation programs using Proc Compare, Log window review, Pinnacle 21 validator

• Data check by _Null_, Proc SQL, Random sampling, subset data, Proc Freq, Proc Means and debug the programs

• Edit Check of the Programs by reviewing log window for errors, warnings, uninitialized messages and resolving by program editing

• Maintain study documentation, archive data

• Developed mini macros for Cleanup, Sort_of, Contents_of

• Used existing programs for efficiency and reusability; Macro utilities. SAS Training (2014):

SAS Institute, North Carolina (2014)

Education & Experience:

• QC Chemist at Chantilly Biopharma, Chantilly, Virginia (2011-2013)

• QC Chemist at IML labs, Sheridan, Wyoming (2009-2011)

• Post doctoral Scientist, Montana State University, Bozeman, MT, USA (2008)

(Development of Site Targeted Drug Delivery entities to treat CNS diseases)

• Post doctoral Research, University of the Witwatersrand, Johannesburg, South Africa (2007)

(Discovery & Development of Cancer Therapeutics)

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• Post doctoral Research, University of Santiago, Santiago De Compostella, Spain (2006)

(Discovery & Development of Cancer Therapeutics)

• Post doctoral Research, University of Saarland, Saarbrucken, Germany (2005)

(Discovery & Development of Cancer Therapeutics)

• Senior Chemist, Dr. Reddy Laboratories (1995-1999)

(Discovery & Development of Anti-Ulceratives, Anti-HIV agents, Anti-Bacterial agents, COX-II inhibitors, Cancer Therapeutics)

• Ph. D in Drug Discovery & Development at IICT, India (2004)

• Masters in Chemistry, OU, India (1993-1995)

• Bachelrs in Life Sciences KU, India (1991)

Publications:

Indian Journal of Chemistry, 1999, 38, 1311-21

Tetrahedron Letters, 2004, 45 (51), 9483-9485

Tetrahedron Letters, 2005, 46, 5239-5242

European Journal of Medicinal Chemistry, 2007, 42(8), 1144-1150 Journal of Medicinal Chemistry, 2008, 51, 4685–4698 Journal of Medicinal Chemistry 2011, 54 (12), 4234-4246

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