Lead Biostatistician

Job Title: Lead Biostatistician  
Location:  Waltham, MA         
Duration:  12 months          

Note:
PK Experience Needed

Job Description:  

  • Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells
  • Performs quality control (source code review, double-programming and log review) of SAS programs
  • Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications
  • Prepares specifications for CDISC and other analysis data sets
  • Assists Data Management with SAS programming needs
  • Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study tea

Requirements:

  • BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
  • 8+ years of experience in SAS programming within the area of clinical trials
  • Prior experience using computerized information systems preferred
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Demonstrated working knowledge of data processing, database design and organization in clinical data environment
  • Demonstrated working knowledge of basic clinical trial design and analysis principles
  • Working knowledge of CDISC standards and application of these standards to projects
  • Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
  • Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
  • Excellent team player, collaborative and able to build an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Is customer service focused in approach to work both internally and externally
  • Maintains a positive, results orientated work environment.
  • Ability to build client confidence and achieving high levels of customer satisfaction
  • Attention to detail and ability to independently work on stand-alone Biostatistical projects with general supervision

















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