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Senior Biostatistician

Company: My New Company
Location: Atlanta
Posted on: November 22, 2021

Job Description:

Role: Senior Biostatistician Location: Remote Working Group: Biostatistical Services Reports to Whom: Global Head, Operations Job Overview Scope of Responsibility/ Level of Oversight, Authority & Independent Decision-Making Provides biostatistics deliverables Exercises a moderate level of independent decision-making Performs tasks and initiatives with minimal guidance Follows established procedures Interaction Interacts with all levels of company personnel, as well as sponsors Key Responsibilities The primary responsibilities of this position include, but are not limited to, the following: Ensures successful completion of high-quality statistical deliverables Writes and/or reviews statistical sections of protocols Assists in protocol study design (determines sample sizes for all phases of trials) Writes Statistical Analysis Plans (SAPs) Writes Tables, Listings and Figures Plans (TLF Plans) Reviews and/or designs Case Report Forms (CRFs) Reviews and/or writes randomization and blinding plans Reviews and/or writes charters for Data Monitoring Committees (DMCs) Provides SAS code for statistical models Validates/performs SAS programming for key data analyses Performs quality control on derived variables being analyzed Interprets results from analysis Maintains documentation Reviews Clinical Study Reports (CSR) Keeps abreast of statistical literature/design Job Requirements:Level of Education Master---s degree in Biostatistics or equivalent, required Prior Experience 5+ years of experience in clinical biostatistics, required-- Prior experience in a CRO/pharmaceutical environment, required Skills and Competencies Expertise in statistical concepts and design Understands the investigational drug development process Demonstrates ability to build and maintain effective relationships with others Strong communication, organizational and decision-making skills High level of agility and diplomacy Must be able to anticipate challenges and project risks and proactively implement solutions Strong time management and effective planning skills Knowledge of Standard Operating Procedures Working knowledge of FDA and ICH guidelines Working knowledge of MS Office and Outlook Thanks & Regards Suraj Prasad Technical Recruiter Siri InfoSolutions Inc. Phone: 732-832-7960 Email ID: Visit us at:

Keywords: My New Company, Atlanta , Senior Biostatistician, Other , Atlanta, Georgia

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