Jyoti(Jo) Agarwal

Email: acn83h@r.postjobfree.com

Mobile:

210-***-****

Address: Brentwood TN 37027

SAS Certified Advanced Programmer with 6+ years of industry experience in analysis, design, development, testing,

and validation for data management and reporting in the Life Sciences, Healthcare and Pharmaceutical fields with 5+

years in Clinical Statistical Programming.

Involved in different Phases of the Clinical Trials in different therapeutics areas such as Oncology,

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Cardiovascular.

Working knowledge of Limited used modules (LUMs Macros) for company level and study specific.

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Experience with Clinical Data Analysis includes creation of Annotated CRFs to SDTM datasets,

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Analysis Datasets, TLGs (Tables, Listings, and Graphs), Reports and Ad hoc reports using Output

Delivery System (ODS).

Created patient profiles and patient summaries.

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Performed data Cleaning Techniques, QC Validation and Edit Checks as per protocol design.

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Experience in Migration procedures, Manipulation procedures, and Statistical procedures.

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Knowledge of Imputation techniques.

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Generated Transport files, XML Files and Data Definition Document.

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Experience in preparation of SAS/Base, SAS/Macro, Proc SQL, SAS/STAT.

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Worked with CDISC SDTM model to develop ADaM and created GAP analysis and mapped

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datasets to SDTM standards using Open CDISC Validator.

Experience in Safety & Efficacy datasets.

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Worked on summaries according to requirements, Standard Operating Procedures ( SOPs), and

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Statistical Analysis Plan (SAP), SDD (SAS Drug Development) tool.

Familiarity with ICH GCP guidelines and Electronic Submission standards.

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Understanding of Pharmacokinetics and Pharmacodynamics property of the drug, developed

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NONMEM analysis dataset for Pharmacometricians to help do the simulation and modelling.

Expertise in CRF/eCRF Annotation with respect to various database designs.

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Created graphs using Data Visualization tool (SPOTFIRE) for Reporting Analysis.

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Knowledge of scripting languages (HTML, XHTML, JavaScript and CSS) for web development.

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Quick learner and excellent team player, ability to meet deadlines and work under pressure.

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Professional Certifications

SAS Certified Advanced Programmer for SAS9 2008

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SAS Certified Base Programmer for SAS9 2008

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Certificate in Banking Competency by TCS FTC (Financial Technology Centre)

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Advanced Diploma in Foreign Language (French) 2006

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Education

Web Developer Specialist Certificate, Austin Community College, USA 2012

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Master of Science in Computers, Banasthali University, India 2006

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Bachelor of Science in Computers & Mathematics, Banasthali University, India 2004

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Technical Skills

SAS Components SAS/Base, SAS/Macro, SAS/STAT, SAS/SQL, SAS/Graph

Open CDISC Validator, SAS LOG Checker, SAS Viewer, SAS Enterprise Guide,

SAS Tools Statistical Drug Development

Web Skills HTML, CSS, JavaScript, CMS integration

Microsoft Visual Studio, Adobe Dreamweaver, Adobe Photoshop CS5,

Front end Tools MS Expression Web

Professional Experience

Triangle Biostatistics LLC, NC, Clinical SAS Programmer (Sep’2014 – Present)

Responsibilities

• Created and reviewed Annotated CRFs to SDTM datasets.

• Generated and Validated Analysis Datasets, TLGs (Tables, Listings, and Graphs), Reports and Ad hoc reports

using Output Delivery System (ODS).

• Worked on the patient profiles and created patient summaries as per the study requirement.

• Exposure to clinical trial data such as Demographic, Adverse Events (AE), Medical Histories, Concomitant

Medications, Laboratory Results and Vital Signs as per Statistical Analysis Plan (SAP).

• Involved in creation and validation of datasets according of CDISC SDTM standards following specifications

document.

• Transferred data between databases using import/export facility in SAS.

• Converting Excel applications to HTML, utilizing ODS.

• Testing a series of SAS programs to generate PDF, HTML and RTF using SAS.

• Reviewed Protocols, Case Report Forms, and Statistical Analysis Plans for Clinical trials.

• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided

descriptive statistics using PROC Means, Frequency, and Univariate.

• Report generation using many SAS procedural statements, SAS/MACROS, and data _null_ steps.

• SAS was used for pre processing data, SQL queries, data analysis, generating reports, and statistical

analyses.

• Processed data collection to ensure proper quality of data and maintained the daily error log for cleaning the

data.

HepTronik Inc., Plainsboro, NJ, Clinical SAS Programmer (Jan’2014 –Aug’2014)

Responsibilities

• Involved in SAS programming with different phases of Clinical Trials data in Oncology.

• Developed dynamic SAS programs using SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT.

• Involved in the development of Clinical Trials analysis datasets Demographics data, Adverse Events (AE),

Serious Adverse Events (SAE), Laboratory data (LB), Physical Examination (PE) data and Vital Signs (VS)

data.

• Plan and co ordinate programming, testing, documentation of analysis programs for use in creating tables,

data listing summaries, and Graphics.

• Validated for tables, listings, analysis datasets and figures for clinical study report.

• Programmed edit checks in quality control process for clinical studies.

• Involved with QC and validation of SAS programs.

• Generated RTF, PDF, and HTML reports, using SAS Output Delivery System.

• Developed company level and study specific macros for generating tables, listings, graphs.

• Involved in the process of generating Tables, Listings, and Figures using PROC Report for Integrated

Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.

• Transported files and data definition document through electronic submission.

• CDISC SDTM/ADaM experience – mapping of various phases of clinical trial data into the SDTM format.

RPP MED, Florida, Clinical SAS Programmer (Oct’2012 Dec’2013)

Responsibilities

• Extracted data using migration procedure (import) from ASCII files to SAS dataset.

• Created and maintained analysis datasets from raw datasets for demographics, drug, therapy, response,

indication, outcome, reaction and integrated dataset including all the datasets.

• Programmed edit checks to satisfy data collection, storage, and analysis for clinical studies.

• Performed validation (using Proc Compare) and Qcing as per protocol design.

• Created AD hoc reports for analysis datasets using Proc Reports and Proc Tabulate.

• Developed Listings, Tables and Graphs for Safety & Efficacy datasets for the clinical studies.

• Automated standard programs using macros.

• NONMEM analysis dataset for different studies which included, derivation of standard variables like EVID,

EPID, DV,NTAFD,NTAPD, ATAFD and ATAPD and other required variable as need for the model.

• Formatted RTF, PDF, and HTML reports, using SAS Output Delivery System.

• Produced descriptive and categorical statistics using Proc Means, Freq, Univariate, and Summary.

• Converted the analyzed datasets into transport (.XPT), XML files and attached a data definition document

(DDD) file for e submission.

• Creating CDISC compliant SDTM domains and generating XML files.

• Developing and validating SDTM and ADaM datasets following CDISC standards.

Eli Lilly and Company, Indianapolis, Indiana SAS Programmer (Oct’2007 Jul’2009)

Responsibilities

Reviewed CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting

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data to meet objectives defined in protocol.

Analyzed requirements and prepared user requirements specification document.

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Developed new or modified SAS programs to load data from the source and create study specific

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

Created, derived and merged analysis.

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The accuracy and integrity of clinical data were verified by performing validation checks written in SAS

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and checked for data related errors, outliers, and missing values

Involved in the analysis of the clinical data (DISPOSITS, SUBJINFO, BOR, CMPTY etc.).

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Worked as a code reviewer (SDYTRT, SDYTRTPK, MD, VISIT, VITALS, etc.).

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Experience in requirement analysis.

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Created macros for various datasets for working towards automation process.

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Implemented CTCAE grade (Toxicity) for Lab values.

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Locked Pharmacometrics databases for various Oncology studies for various indications.

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Worked in tandem with team including programmers, bio statisticians, PK Scientists and provided

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timely and effective communication to the programming and PK (Pharmacokinetic) leads.

Analyzed pre dose samples for Below Limit of Quantification (BLQs) and quantifiable samples.

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Took lead in weekly meeting.

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Prepared validation document and edit checks for e CRFs.

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Provided SAS & SDD training to the new joiners.

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National Bank of Kuwait, Kuwait Front end Developer (Jan’2007 Oct’2007)

Responsibilities

Involved in client specific web development.

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Worked with designers to create templates and sliced images

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Built client side code for web application using HTML, CSS, and JavaScript.

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Created clean, well documented, standards compliant (W3C) websites.

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Worked with basic PHP to interact with the back end code.

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Participation in design report and in weekly design review meetings.

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Network Programs, India Software Intern (Aug’2006 Jan’2007)

Responsibilities

Worked on manual testing of Java based application.

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Responsibilities included integration and system testing and sharing testing results with development

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team.

Datanet Technologies, India Internship (Jan’2006 Jul’2006)

Responsibilities

Experience in designing dynamic and static pages.

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Creating web templates using HTML and CSS, newsletters, logos, brochures, business cards.

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Researching and recommending the web design as per the market trend.

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