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Director Statistical Programming

  • Job type: Permanent
  • Location: Kenmore
  • Salary: $220000 - $240000 per annum, Benefits: Bonus + Complete Benefits Package
  • Job reference: MASL121817845
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 18/12/2017
Director Statistical Programming

  • Statistical Programming| FDA Submissions | Phase I-IV Clinical Trials | 8 + years of oncology clinical trial experience 
  • Greater Seattle Area 
  • $220,000 - $240,000 +complete benefits package         
Exciting Director opportunity with growing Biotech company. The Director of Stat Programming will be responsible for overseeing TOTAL statistical programming functions to support of clinical development programs. The director wil be responsible for the design of statistical protocols for clinical programs as well as having an executive role in leading regulatory submission and global health outcome efforts.  

The Director of Stat Programming will have responsibilities that includes
  • Management of all programming teams
  • Responsible for leading FDA/EMA meetings as well as Advisory committee meetings
  • Active participation on the protocol development team by providing statistical insight and guidance
  • Contributing to vendor section and management
  • Providing operational statistical programming expertise to stage I-IV clinical trials
  • Writing and reviewing SAP as well as statistical protocols and SOPs
  • Management of all of SDTM data set
The ideal candidate will have :
  • A minimum of 15 years of experience in the Pharmaceutical industry
  • at least 8 years of oncology clinical trial experience 
  • Experience managing statistical programming teams 
  • Experience with following guidelines/regulations for FDA submissions
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