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Sr. Biostatistician
Ref No.: 17-04126
Location: Madison, New Jersey
Position Type:Contract
Experience Level: 3 Years
Start Date / End Date: 11/06/2017 to 05/06/2018
Description
Under general supervision, provides statistical support in the design and analysis of clinical trials. Reviews the statistical aspects of clinical study design, prepares assigned sections. Performs statistical analyses. Develops and/or executes analysis plans, and interprets the results. Essential functions include:

• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Assists in the development of clinical trial designs including the selection of appropriate statistical methods and tests, sample size calculations and creation of randomization schedules.
• Perform statistical analyses of clinical trial data
• Reviews the design and content of Case Report Forms, databases, and data edit checks.
• Prepare statistical analysis plans or analysis mockup shells for tables/figures/listings
• Develops and validates SAS programs to support statistical analyses.
• Executes statistical analysis plans including generation of tables, listings, and figures.
• Provides interpretations of statistical results and prepares the relevant statistical sections for clinical study reports.
• Creates and maintains biostatistical documentation, including descriptions of methods,
SAS programs and results.
• Prepares electronic files in the appropriate format for submission to regulatory agencies.
• Participates in the development of standardization procedures for statistical functions.
• Evaluates and proposes new statistical methods for data analysis.
• Reviews statistical analysis plans, SAS programs, and tables, listings, and figures.
• Performs related duties as assigned.

PhD in statistics or biostatistics from an accredited college or university with one (1) year experience in clinical trial statistics, or a MS in statistics or biostatistics with 2-3 years of experience in clinical trials.
Knowledge of:
• General statistical principles and methods.
• Statistical programming including working knowledge of SAS.
• Database structures and data handling procedures.
• Business and scientific software applications.
• Business English usage, spelling, grammar and punctuation.
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