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      Inspection Readiness Lead

      Made ScientificPrinceton, NJ

      818 Biomedical Engineer jobs in Helmetta, NJ

      New, Posted 19 hours ago
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      IT Biomedical Radiology Equipment Specialist

      Hackensack Meridian Health

      Neptune, NJ 07753

      New, Posted 9 hours ago
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      Staff Design Verification Engineer

      1010 Analog Devices

      Somerset, NJ 08875

      Health InsurancePaid Time OffRetirement Benefit
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      Associate Director, Biostatistics

      Genmab

      Plainsboro, NJ 08536

      RemoteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

      • Experience in statistical analysis, modelling and simulation and adaptive trial designs
      • 8+ years of experience in relevant area preferred, or demonstrated capability
      • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
      • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
      • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
      • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
      • Master's or PhD in a statistical discipline
      • Experience directing multiple complex projects/studies in a technical capacity
      • Experience with the relevant regulatory requirements for biostatistics processes and SOPs
      • Proven performance in earlier role/comparable role
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      VP; Sftwr Engineer

      BofA Securities

      New York, NY 10060

      $189,600-$199,600/yr
      Onsite

      • Enhancing & maintaining high traffic intranet web apps using Java & cutting edge Devops technologies incl. OpenShift & Ansible
      • 5 yrs exp. in: Designing & developing production ready sftwr using web, cloud & distributed technologies incl. Apache Spark, Hadoop, Microservices, & CI/CD cloud deployment
      • Bach. or equiv.
      SmartExplore AI is experimental.

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