EDATAKA A contract research Organization
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Contact Edataka
To work with Edataka, or just to learn more about us, including our full suite of end-to-end clinical services, advanced technologies, and the people who make it all happen, contact us at (609)-647-7550 or send a email
POSITION:
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.