Resume

Sign in

Data Clinical

Location:
Fremont, California, United States
Posted:
October 26, 2016

Contact this candidate

Name: Dipal Patel

Skills: SAS Programmer

Contact No: 321-***-****

Email: acw83o@r.postjobfree.com

Address: *** ****** ****** ****, *** 160,

Fremont, CA 94536.

Objective

To obtain a position in which the skills and knowledge attained can be fully utilized for the better of the company as well as its employee’s investors and customers.

Summary

SAS Programmer with over 6 years of industry experience as a SAS programmer .

Over 6 years of experience in Clinical Trials in Pharmaceutical and Medical Research industries. excellent experience in analyzing safety and efficacy data for of clinical trials.

Extensive experience in using various SAS tools like SAS/BASE, SAS MACROS, SAS/STAT, SAS/GRAPH, SAS ODS, CDISC SDTM and SAS SQL.

Experience in debugging, validating and improving on existing SAS programs.

Excellent work experience in generating reports, tables, listings, and graphs according to Statistical Analysis Plan, Standard Operating Procedures (SOPs) and departmental guidelines. This involved use of base SAS procedures such as REPORT, SUMMARY, EXPORT, TABULATE, UNIVARIATE, FREQ and statistical procedures like TTEST, MEANS.

Ability to give strong attention to detail and good communication skills.

Experienced and proficient in using SAS LIBNAME SAS/ACCESS SQL pass through facility to write queries for pulling data from oracle and Access databases.

Technical Skills:

Operating Systems: Windows 98/NT/2000/XP

Statistical Software: SAS 9.2 (BASE, STAT, ACCESS, MACROS,SQL, GRAPH),

SAS Procs: SQL, REPORT, MEANS, UNIVARIATE, TABULATE, FREQ, CHART, SORT, SUMMARY, CONTENTS, FORMAT, IMPORT, EXPORT, APPEND, TRANSPOSE, PLOT.

Languages: HTML, SQL,

Databases: MS Access 2K/97

Work Experience:

Client: GSK, Research Triangle Park, NC Jan 2016 – Oct 2016

Role: Sr. Clinical SAS Programmer

GSK conducts clinical trials in many therapeutic areas with a special emphasis in the oncology, pharmacokinetics, central nervous system, allergy and respiratory disease. GSK’s Clinical research Center at NC designs and coordinates clinical drug trials locally and around the world. GSK also analyzes results from clinical trials and prepares them for submission to the U.S. Food and Drug Administration.

Projects included: Study on oral cavity cancer, Phase II trial studies how trametinib affects tumor cells in patients with oral cavity squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by blocking an enzyme pathway needed for cell growth.

Responsibilities

Involved in writing, analyzing, and presenting of clinical trial reports for Phase I and II of clinical trials.

Accessed SAS clinical tables using SAS Access facility to connect to oracle database.

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

Used BASE SAS to perform sorting, indexing, merging of the datasets.

Worked on data analysis, statistical analysis and generated reports, listings and graphs using BASE SAS and SAS procedures such as PROC SUMMARY, PROC TABULATE, PROC FREQ and PROC PLOT, SAS GRAPH, PROC SQL and ODS procedure.

Extensively used SAS/MACRO facility to provide reusable programs that can be conveniently used time to time and created tables, graphs and listing reports.

Reviewed protocol documents, case report forms, and statistical analysis plans for clinical trials.

Responsible for writing and debugging statistical programming and documented programming procedures.

Developed reports using PROC REPORTS, PROC TABULATE and DATA_NULL_.

Used interleaving, one-to-one, concatenating, merging, and appending techniques to combine SAS datasets.

Debugged, validated and improved on existing SAS programs.

Established and maintained sound working relationship and effective communication.

Environment: SAS/BASE, SAS/GRAPH, SAS/MACRO, SAS/STAT, Windows NT

Client Name: PRA International, Inc. Lenexa, KS September 2015 – December 2015

Role: SAS Programmer – Clinical Trial

Description:

PRA conducts clinical trials in many therapeutic areas with a special emphasis in the areas of oncology, central nervous system, allergy and respiratory and cardiovascular disorders. PRA’s Clinical Pharmacology Center at Lenexa designs and coordinates clinical drug trials locally and around the world. PRA also analyzes results from clinical trials and prepares them for submission to the U.S. Food and Drug Administration. Projects included: A Randomized Phase III, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia(therapeutic area: Urology); A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX(an equivalence trial).

Responsibilities:

Worked on Phases I - III of Clinical Trials and performed Clinical Data Analysis and generated SAS Datasets by importing from various sources like Excel datasheets and flat files.

Exported PDF files for regulatory submission.

Developed reports using PROC REPORTS, PROC TABULATE, and DATA_NULL_.

Generated statistical summary tables, graphs, and patient data listings for Phase I and Phase II of clinical trials using base SAS procedures such as PROC SUMMARY, PROC TABULATE and SAS GRAPH.

Extensive use of SAS/BASE and SAS/STAT for producing tables, listings, figures, and generating statistical reports.

Developed reusable SAS Macros to verify data, create tables, graphs, and listings for inclusion in clinical study reports, and regulatory submissions and maintained existing ones.

Used procedures like PROC FREQ, PROC MEANS, PROC SORT, PROC PRINT, PROC UNIVARIATE, PROC TTEST, and PROC GPLOT.

Used Output Delivery System (ODS) facility to write custom safety and efficacy reports in PDF, RTF and HTML formats.

Used CDISC SDTM to convert the tabulations in company’s standards to FDA standard tabulations.

Used interleaving, one-to-one, concatenating, merging, and appending techniques to combine SAS datasets.

Environment: SAS/BASE, SAS/GRAPH, SAS/MACRO, SAS/STAT, Windows NT, LINUX

Client Name: Divis Laboratories March. 2013 – August. 2015

Role: SAS Programmer – Clinical Trials

The Group's principal activities are to develop and commercialize a portfolio of novel treatments for both early and late stage cancers. Project: A phase III, multi-center, randomized, double-blind, placebo-controlled study of marimastat in patients with minimal disease stage III, non-small cell lung cancer. Compare the effect of marimastat (a matrix metalloproteinase inhibitor) vs. placebo on overall survival in patients with Stage III non-small cell lung cancer who have minimal residual disease following chemotherapy, radiotherapy, and/or surgery and assess the effect of marimastat on time to disease progression in these patients. Assess the safety and tolerability of marimastat in these patients.

Responsibilities:

I worked on Phases I and II clinical trials.

Imported data from Access and Oracle using SAS/ACCESS LIBNAME statement and SAS/ACCESS SQL Pass-Through Facility

Cleaned/verified and validated clinical data using SAS MACROS.

Coded data using MedDRA.

Implemented CDISC SDTM standards.

Developed SAS analysis datasets for drugs under study.

Created TLG’s using procedures like DATA_NULL_, PROC REPORT, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC MEANS, and PROC UNIVARIATE.

Client: Techsol corporations, India June. 2011 - February. 2013

Role: SAS Programmer – Clinical Trials

The mission of the institute is to carry out scientific research concerning communicable diseases, especially viral diseases of public health importance and to advise the government on strategies for control and prevention. Project: A Phase I Study of the Safety and Immunogenicity of Live Recombinant ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers in Uganda. This project was funded by the National Institute of Allergy and Infectious Diseases (NIAID). Study design: Prevention, Double-Blind, Safety Study.

Responsibilities:

Contributing to the development and documentation of analysis/clinical data set specifications, safety and efficacy analysis programming, as well as any ad-hoc programming requests.

Developing data listings, summaries, and graphs for statistical analysis and/or report writing using DATA_NULL_, PROC REPORT, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC MEANS, and PROC UNIVARIATE.

Reviewing data to verify integrity and consistency for completeness, accuracy and suitability, including data adherence to protocol, data coding integrity, reliability of collection and interpretation

Worked with ADAM SDTM model for standardization of dataset.

Creating SAS programs according to requirements specifications and following SOPs to produce accurate and timely results.

Performing statistical analysis under the direction of organization’s statisticians.

Maintaining organized, complete and up-to-date study documentation, testing and validation/quality control documents and programs in compliance with the National Drug Authority (NDA) standards.

Performing peer reviews, which included reviewing code, confirming accuracy of results, conforming to client style guidelines and/or Sponsor guidelines

Environment: SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/GRAPH, Excel, SPSS.

Education:

Centre for Management Studies, Ganpat University. (2011-2013)

Masters of Business Administration (Pharmaceuticals).

GPA= 4.0/4.0

B.S Patel Pharmacy College, Hemchandracharya North Gujarat University, India (2007-2011)

Bachelor of Pharmacy.

GPA= 3.5/4.0



Contact this candidate