Project Manager Data

JAIN HARDIK

Email: - ******.****@*****.***

Call: - 201-***-****

Summary:

• Certified SAS programmer with broad based and progressively consulting experience in the clinical trial data

management

• Expert in SAS/BASE, SAS DATASETS, SAS/STAT, SAS/GRAPH, SAS/MACRO, and SAS/SQL.

• Extensive knowledge in SAS Programming, merging SAS Datasets, Macro Facility, PROCs, Producing Reports,

SAS Formats, SAS Functions, Storing and Managing Data in SAS Files.

• Proficient in preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to

the Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP) and departmental guidelines.

• Expert in concatenating, interleaving, and merging SAS datasets.

• Knowledge of 21 CFR Part 11 and other Regulatory Agency Standards like ICH & GCP.

• Thorough knowledge in Clinical Trials Data like Demographic Data (DM), Adverse Events (AE), Serious Adverse

Events (SAE), Laboratory Data (LB), Concomitant Medication (CM), Substance Use (SU), Physical Examination

(PE) and Vital Signs (VS).

• Experience working on Phase I, II, III of Clinical Trials in pharmaceutical industry.

• Excellent knowledge of statistical SAS procedures like FREQ, UNIVARIATE, APPEND, MEANS, GLM, SUMMARY,

REG and ANOVA & reporting SAS procedures like REPORT, PRINT and TABULATE.

• Experienced in producing HTML, RTF and PDF formatted files using SAS/ODS.

• Working knowledge in the CDISC and MedDRA, WHODrug Regulated Environment.

Skills:

SAS Skills: SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS,

SAS/CONNECT, SAS/ODS, SAS EG, Proc Freq, Proc Transpose, Proc Report,

ProcTabulate, Proc Univariate, Proc Means, Proc Summary, Proc CDISC, Proc

Anova,Data_Null_, Proc GLM, Proc Compare, Proc TTEST and many more.

Database: MS Access 98/2000 Oracle, MS SQL Server

Languages: SAS, SQL

Operating Systems: Windows 98/XP/VISTA, UNIX

Tools: WordPerfect, MS Office, MS Word, Power Point, MS Excel

Education:

• University Masters Degree.

• Post Graduate in Pharmacy.

• SAS Certified Base Programmer for SAS 9

Experience:

Amneal Pharmaceuticals, LLC, Hauppauge, NY Oct 08 – May 10

Clinical SAS Programmer

Amneal Pharmaceuticals is a CRO/ pharmaceutical company with presence across the value chain which produce

safe, innovative and high quality finished dosage forms. As a SAS programmer I was involve in multiple phase like

Phase-III clinical trial of Dyspepsia and phase-I clinical trial of Anti-neoplastic drug.

Responsibilities:

• Comprehensive skills in working with SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS

etc. in Windows and UNIX environment (PC/SAS).

• Produced data listings, summary tables and graphics for interim and final analyses and publications.

• Verified accuracy and integrity of Clinical Data by performing validation checks written in SAS and investigate data

related errors, outliers, and missing values.

• Developed standard reports for safety data including Adverse Events summaries for IND (Investigational

New Drug) and Post-Marketing Safety Reports.

• Used Base SAS (MEANS, FREQ, TABULATE, REPORT etc) and SAS/STAT procedures (REG, TTEST GLM,

ANOVA, UNIVARIATE etc.) for summarization, Cross-Tabulations and statistical analysis purposes. The generated

reports are reviewed and then sent to the FDA.

• Produced RTF, MSWORD and HTML formatted files using SAS/ODS to produce ADHOC reports for presentation

and further analysis.

• Run various queries and ad-hoc reports according to the Users requirement.

• Performed CRF review, design and quality check.

• Prepared and developed data review procedure requests, data error detection, data management, data retrieval,

and data listings.

• Coordinated the integration of Clinical Trial databases to support creation of integrated summaries of safety and

efficiency.

• Installed and maintained statistical software as needed.

• Worked with different Clinical Trials Data like Demographic (DM), Adverse Event (AE) data using MedDRA,

concomitant medication (CM), Substance Use (SU), Laboratory, and Physical examination.

• Developed CRT for Clinical Trial analysis and Electronic submissions to FDA (21 CFR Part 11).

• Worked with Clinicians, Statisticians and Data Managers to design and develop Project Database and create

analysis Datasets for Projects and Individual trials.

• Developed and executed advanced SAS/Macro to monitor ongoing studies, produced data listing, summary tables

and graphics for interim and final analyses for the organization.

• Involved in writing code-using Base SAS & SAS/Macros to extract clean and validate data from oracle tables.

• Developed new and modified SAS programs to load data from the source and created study specific datasets,

which are used as source datasets for report generating programs

Environment: Base SAS, SAS/Macros, SAS/SQL, SAS/Access, SAS/Stat, SAS/ODS, SAS/Graph, MS Excel,

Proc Print, Proc Tabulate, Proc Summary, Proc SQL, Proc Format, Proc Freq, Windows XP

Par Pharmaceuticals, Spring Valley, NY Jun 07 – Sep 08

SAS Programmer

Par Pharmaceuticals conducts Clinical Trials to evaluate the safety and effectiveness of their products. These trials are

fundamental to the development of innovative medicines and vaccines that treat and prevent illness. As a sas

programmer I was involve in the phase III clinical trial of Anti-psychotic drug.

Responsibilities:

• Participated in the Phase-III Anti-psychotic Clinical Trial.

• Reading SAS data sets and creating variables.

• Import and Export data using importing and exporting techniques in SAS.

• concatenation and merging SAS Data Sets, Macro Facility, Preparing Data, Producing

• Reports, SAS Formats, SAS Functions, Storing and Managing Data in SAS Files.

• Producing reports employing various SAS Procedures like Print, Report, Summary, Freq, Tabulate, Means, SQL,

and Datasets.

• Conversions of SAS Datasets to various files types (including Excel, RTF, PDF, and HTML) as well as converting

various file types to SAS Datasets.

• Listing and summary tables to report the results of Clinical Trials.

• Wrote SQL Queries to check data for different conditions like duplicate values and missing values.

• Produce validation on the data and dataset using Proc Freq and Proc Format.

• Accessing data from Oracle database and SAS data sets.

• Developing graphs regarding the response levels of the patient.

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS Macro, SAS/ACCESS, and UNIX

Core Pharma, Middlesex, NJ Mar 06 – Apr 07

SAS Programmer

Core Pharma is currently conducting Clinical Trials for a number of diseases. As a sas programmer I was involve in the

phase II clinical trial of Chronic Kidney Dieses(CKD).

Responsibilities:

• Generated Safety data summary Tables/ Listings/ Figures for Clinical Study Reports.

• Participated in Phase II of the Clinical Trials.

• Extracted the MS Access/ MS Excel file to SAS using the Proc Import, SAS/ ACCESS and SQL Pass Through

Facility on Windows.

• Converted raw data from different formats (Text Files, Excel, and Access) to SAS datasets.

• Performed data cleaning and Integrity checks using SAS/SQL, SAS/Macro and various DATA steps.

• Created various graphs such as Kaplan Meier Survival Estimates, Scatter Plots and Bar charts using SAS/GRAPH

• Created HTML and RTF reports, using SAS output delivery system.

• Reviewed Protocol and Statistical Analysis Plan (SAP).

• Interacted with Project Manager, Bio statistician and other cross-functional team members.

• Modified existing SAS Macro programs as well as created at certain point for statistical analysis as needed.

• Generated quality customized reports by using Proc REPORT, Proc TABULATE, Proc SUMMARY and DATA

_NULL_.

Environment: BASE SAS, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ODS, Windows 2000, MS Excel, Oracle

Clinical

Veeda Clinical Research, Ahmedabad, India Jan 05 – Dec

05

SAS Programmer

Veeda Clinical Research is a full service global CRO specializing in the early clinical development of drugs with a

multiple research centers in India, U.K. and Belgium.

Responsibilities:

• Worked as statistical SAS programmer for phase II Clinical Trials.

• Generated Clinical Data summary Tables/ Listings/ Graphs using SAS for Clinical Study Reports for Phase

I and Phase II trials.

• Extracted data from RDBMS to SAS by using SAS/Access and SAS/SQL Pass through Facility for analysis.

• Created the derived data to perform analysis as per statistician specifications.

• Cleaned the data using the SAS procedures such as Proc Freq for Categorical Variables and Proc

Univariate for Continuous Variables.

• Used Base SAS procedures such as Proc REPORT, Proc PRINT, Proc CONTENTS, Proc SORT, Proc

TABULATE, Proc GPLOT, and Proc MEANS.

• Clarified the observed issues with Team Leader, Project Manager and Bio- Statistician across the programming.

• Using ODS created PDF and RTF output.

Environment: Base SAS, SAS/Macros, SAS/SQL, SAS/Access, SAS/Stat, SAS/ODS, SAS/Graph, Proc Print,

Proc Tabulate, Proc Summary, Proc SQL, Proc Format, Proc Freq, Windows XP

References: - Excellent, Valid and available Upon Request.

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