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Director of Stat Programming

  • Job type: Permanent
  • Location: Boston
  • Salary: Competitive
  • Job reference: jeyo10/26/17120466
  • Sector: Clinical, Clinical Operartions, EPM Scientific
  • Date posted: 22/11/2017
Director Statistical Programming 
  • Statistical Programming| FDA Submissions | Phase I-IV Clinical Trials
  • Greater Boston Area
  • $00,000 - $230,000 +complete benefits package         
A Biotech company is looking to hire a Director of Stat Programming that would be responsible for all statistical programming functions in support of clinical development programs. The Director of Stat Programming will play a key role in designing new statistical protocols for clinical programs as well as working to lead regulatory submission and global health outcome efforts.  

The Director of Stat Programming will have responsibilities that include:
  • Overseeing all of the programming teams
  • Serving as the leader for FDA/EMA meetings and Advisory committee meetings
  • Act as an active member of the protocol development team by providing statistical insight and guidance
  • Contributing to vendor section and management
  • Providing operational statistical programming expertise for early to late phase clinical trial programs
  • Writing and reviewing SAP as well as statistical protocols and SOPs
  • Overseeing 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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