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Hiring for Senior Biostatistician with 100% Remote

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Siri Infosolutions Inc

2021-12-03 07:32:18

Job location Washington, District of Columbia, United States

Job type: fulltime

Job industry: Science & Technology

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

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.

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