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POSITION:

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Edataka LLC is looking for a professional Statistical programmer to work on our client’s clinical research

project.

General Responsibilities

:



Coordinate with project manager, assist in reviewing statistical analysis plan (SAP), study

protocol, CRF, and analysis file specifications to ensure SAS codes are incompliance with the

requirement of SAP and study protocol.



Provide SAS programming support for the preparation of integrated reports and FDA submission.



Develop and validate complex SAS programs, SAS macros to create tables, graphs and listings,

generate and validate SDTM and ADaM datasets for multiple phase I- III studies, integrated

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



Provide SAS programming specifications for CDISC SDTM and ADaM datasets, including

proper validation, testing and documentation.



Gather

and interpret safety and efficacy data that are collected during clinical trials,

review data

collection and management methodology and assure acceptability and scientific integrity of data

collection and analysis through appropriate application of principles of probability and statistical

methodology.



Use statistical

techniques to analyze the clinical data and generate Ad-hoc safety summary reports

for review by research scientists and medical directors. Also be responsible for checking whether

the data are out of range of any safety guidelines provided by FDA or other agencies.

Communicate with project manager and notify client in a timely manner on any abnormal testing

results.



Create and modify standard SAS macros for validation, analysis and generation of clinical

reports;

provide high quality statistical analyses

support for the

clinical trial studies using

advanced statistical theory and SAS/STAT/MACRO/GRAPH/SQL

techniques.



Participate in preparing clinical study results for FDA submissions using SAS; writing intense

QC documentation for every stage of reporting from extraction to the final reporting of the tables.



In addition, communicate with project manager

and assist in client's inquiries on clinical trial

related statistical analysis with developing statistical techniques/tools.

Requirements: at least bachelor’s degree or equivalent in Statistics, Applied Mathematics or related

fields with extensive knowledge of statistics, statistical methods and strong skills in SAS programming,

data analysis and data mining for clinical study. Master’s degree is preferred.

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