Lead Statistical Analyst - Oncology

Whippany, New Jersey | Contract

Post Date: 04/21/2017 Job ID: 14494 Industry: MISC

Lead Statistical Analyst - Oncology
Whippany, NJ

The primary responsibility of the Lead Statistical Analyst is to work independently and assume responsibility for the development and use of standard programs and statistical project data structures for all clinical studies within the assigned Study/Project. 

POSITION DUTIES & RESPONSIBILITIES 

  • Provide statistical programming support for assigned clinical study study/project 
  • Coordinate activities of assigned statistical programming team members 
  • Ensure the development of programs and use of project standards for all analysis datasets, tables, listings and figures for assigned project with close cooperation with the study/project statistician. 
  • Participate in the IND/NDA activities, as needed for assigned project 
  • Lead and oversee all statistical programming function deliverables required for submissions to regulatory authorities for assigned projects/studies 
  • Participate on global teams that evaluate processes and make suggestions for process and system needs and improvements 
  • Provide assistance to junior and external programmers in the development of statistical programs
  • Works in close cooperation with other Clinical Operations departments 

REQUIREMENTS

  • BS/MS/PhD in Statistics, Mathematics, Computer Science or equivalent (of theoretical/technical depth). 
  • Must have background working in Medical Affairs or Oncology
  • 3-5 years statistical programming with SAS in pharmaceutical or biotech with experience in creating and validating SDTM and/or ADaM data structures. 
  • Must be well versed with the life cycle of clinical studies, LSH experience, programming tables, be familiar with industry compliance, will be working on statistical analysis of completed studies (POST HOC) and doing some exploratory analysis
  • Excellent demonstrated interpersonal, presentation and communication skills. 
  • Excellent computer skills and database management knowledge 
  • Ability to manage multiple issues and meet & negotiate tight timelines 

Preferences: 

  • Project management or equivalent experience would be an asset

Travis Heider
IT Recruiter

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