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Director Statistical Programming Position with Expanding Biotech Company

  • Job type: Permanent
  • Location: Cambridge
  • Salary: $220000 - $240000 per annum, Benefits: Bonus + Complete Benefits Package
  • Job reference: MASL111517838
  • Sector: Biostatistics, EPM Scientific, Pharmacology
  • Date posted: 21/11/2017
Director Statistical Programming 

  • Statistical Programming| FDA Submissions | Phase I-IV Clinical Trials
  • Cambridge, Massachusetts
  • $220,000 - $240,000 +complete benefits package         
Exciting opportunity with Biotech company seeking a Director of Stat Programming. This role would be responsible for overseeing all statistical programming functions in support of clinical development programs. This position plays a crucial role in designing new 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 sets
The ideal candidate will have the following skill set:
  • 10+ years in stat programming in life sciences preferred.
  • Experience with managing complex statistical data and with analytic statistical software
  • Experience with FDA regulatory submissions
  • Familiarity with CDISC relating to FDA/EMA guidelines
  • 7+ years of experience in managing stat programming teams
  • Phase I-IV clinical trial experience 
  • Excellent verbal and written skills
  • Advanced degree strongly preferred
 

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