OBJECTIVE

An ambitious and technologically skilled individual with excellent interpersonal and organizational competences and having 5+ years of computer programming experience seeking an entry-level Clinical SAS Programmer position.

PROFESSIONAL SUMMARY

Hands-on experience in Clinical SAS programming with a good knowledge in data capture, analysis, design, testing and validating, reporting and documenting according to Statistical Analysis Plan (SAP) and Clinical Protocols to meet business requirements.

Expertise in SAS programming for statistical analysis of clinical data by creating, formatting, and reporting datasets using BASE SAS, SAS/MACRO, SAS/GRAPH, SAS/SQL SAS/STAT, SAS/ACCESS, SAS/ODS and procedures like PROC IMPORT, EXPORT, FORMAT, SORT, MEANS, FREQ, UNIVARIATE, SUMMARY, GLM, REPORT, PRINT, TABULATE, TRANSPOSE, GCHART, GPLOT etc.

Thorough understanding of all phases of clinical trial studies, CDISC SDTM, FDA, GCP/ICH guidelines etc.

Proficient in understanding Clinical study documentation - Study Protocol, Design document, Data management plan, SAP (Statistical Analysis Plan) and CRF (Case report Form).

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

Self-Starter possessing excellent Communication and Analytical skills along with the ability to adapt in a new environment.

TOOLS AND TECHNOLOGIES:

Statistical tools

SAS v 9.x/8.x/6.x

SAS Tools

SAS/Base SAS/Stat SAS/Graph SAS/SQL SAS/Access SAS/Connect SAS/ODS SAS/Report SAS/MACROS

Database

Oracle SQL Server 2000 PL/SQL

Languages

PL/SQL C/C++ JAVA UNIX Shell Scripting

Operating systems

UNIX WINDOWS XP/1998/2000/7

ERP Tools

Oracle E-Business Suite R12, R11 (SCM and Finance)

Other Tools

Microsoft Office Suite (Word, Excel, PowerPoint, Access and Outlook

EMPLOYMENT SUMMARY

Confidential Jan_2016 – Apr 2016

Role: Clinical SAS Programmer Trainee

Responsibilities:

Created Analysis Datasets, Summary Tables, Listings and Plots for statistical analysis in accordance to the CDISC standards.

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

Verified the accuracy and integrity of clinical data by performing validation checks and quality control checks according to the different QC levels.

Macros were written at various instances for automating listings and graphing of clinical data for analysis.

Extensively worked with complex and huge datasets, and generated reports in various formats such as PDF, RTF, HTML and list files.

Generated CRT (Case Report Tabulation) datasets using CDISC standards for FDA regulatory submissions.

Review and acquire knowledge about documents related to clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).

Oracle India Pvt. Ltd. Dec 8 2010 – Feb 12 2014

Role: Oracle ERP consultant

Responsibilities:

Understanding As-Is business process, Business process requirement gathering, process mapping to EBS

Application configuration/setup for procurement and financial modules in the various instances of the release life cycle.

Preparation of functional specification (MD 050) document for customization.

Coordinate and perform end to end functionality testing on all instances of upgrade stages viz. PPB, CRP, UAT and performance.

Remediation, customization and migration of R12 Reports, Forms, Custom, Packages, Workflow, OAF from 11i to R12 and assist with data migration.

Writing PL/SQL Procedures, APIs, Packages, Functions, Triggers and other database objects for Workflows, Reports and Forms.

Poornam Infovision Pvt. Ltd. May 12 2010 – Oct 25 2010

Role: Technical Support – Linux server administration and Web hosting

Responsibilities:

Administration of Linux servers, monitoring and responding to event notifications (Service outages, High load alerts etc.), MySQL database administration

Configure and support Web servers, Mail servers, DNS, VPN, Firewall, Apache compilation with PHP etc.

Hosting control panels like Cpanel, Plesk (setting up accounts, backup and restore, DNS clustering)

EDUCATION

Model Engineering College, CUSAT University – Cochin, Kerala, India (2006-2010)

Bachelor of Technology in Electronics and Biomedical

EMPLOYMENT AUTHORIZATION

EAD (No Visa Sponsorship required)

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