Please reply to *hab...@mutexsystems.com <hab...@mutexsystems.com>*
Must need Visa copy with Rate confirmation

Job Title: SAS Developer
Location: Nashville, TN
Duration: 6 Months +
Billing rate: $50.00 per/Hour

Detailed JD:
Responsibilities:
1)      Represent biostatistics department on project teams, provide
support and guidance on data and statistical-related issues to the teams
2)      Provide statistical input and support related to trial design and
in the development of protocol synopses, protocols and CRFs.
3)      Advise Data Management with respect to database design, validation
checks & key data, to ensure that all data required for analysis purposes
are captured adequately
4)      Develop randomization schema
5)      Develop statistical analysis plans (SAP)
6)      Perform data review to ensure data are suitable for analysis
7)      Work with the programmers to provide definitions, specifications,
documentations and review of derived datasets required to produce the
planned statistical outputs, including tables, figures and listings
8)      Produce statistical outputs for various analysis and reporting
purposes, and provide statistical review and program validation for each
project, to ensure the integrity, adequacy and accuracy of the outputs.
9)      Provide statistical insight in the interpretation and discussion of
study results, and provide statistical contribution to the integrated
clinical study reports and publications
10)   Maintain professional statistical standards by keeping abreast of new
developments in statistics, drug development and regulatory guidance
through literature review and attendance/participation at workshops and
professional meetings
11)   Understand and apply regulatory guidelines/developments and industry
standards/best practices on statistics and SAS programming
12)  Contribute to the development and implementation of internal process
improvement initiatives

Knowledge & Skills
1)      Hands-on experience and knowledge with SAS and other statistical
software along with SDTM and Macro programming.
2)      Good knowledge in applied statistics including study design
methodologies, categorical data analysis, survival analysis etc.
3)      Exposure to the use of modeling and simulation to enhance clinical
trial design and decision making would be advantageous.
4)      Good understanding of clinical research and drug development
process, and requirements on  regulatory submissions and compliance
5)      Familiar with ICH guidelines, regulatory requirements and industry
standards (eg CDISC) and awareness of best practices related to statistical
and programming activities
6)      Excellent verbal and written communication skills and presentation
skills Patient / Customer-focused



Thanks,
Habeeb
Work: 908-822-8515 Ext: 22
hab...@mutexsystems.com

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