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Technical Lead – Business Analyst
Ref No.: 18-27103
Location: Quincy, Massachusetts
Position Type:Contract
Experience Level: 10 Years
Start Date: 04/19/2018
 
Roles and Responsibilities
 
  • 10+ years of IT or Software technical experience in pharmaceutical, medical device or Biotech companies.
  • Implementation, Support, or use of applications that implement statistical methods and analysis pipelines such as R and or MATLAB.
  • Written and validated Matlab or R scripts in a regulated environment. (Pharma, medical device, healthcare.)
  • Strong knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211.
  • Domain Knowledge of PK/PD applications in the research and clinical setting.  Experience with NONMEM, Phoenix WinNonlin, PsN, Pirana/JS, Monolix a plus.
  • Displays strong technical acumen.  Suggests technical alternatives to roadblocks and bottlenecks.   Able to work within teams to achieve business goals with professionalism and poise
  • Proven track record of managing deadlines and scheduling workload.
  • Ability to understand large complex processes in a stressful environment
  • Ability to work independently as well as have ability/willingness to work in team environment.
  • Familiar with development environments in the cloud, a plus.  
  • Ability to work independently as well as have ability/willingness to work in team environment.