1070 Asp.net jobs in Wayland, MA
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Associate Director, Biostatistics

Genmab

South Grafton, MA

RemoteUrgently HiringEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

  • Experience in statistical analysis, modelling and simulation and adaptive trial designs
  • 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
  • Master's or PhD in a statistical discipline
  • Experience directing multiple complex projects/studies in a technical capacity
  • 8+ years of experience in relevant technical area
  • Experience with the relevant regulatory requirements for biostatistics processes and SOPs
  • Proven performance in earlier role/comparable role
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Team Lead, Associate Director, Global Regulatory Affairs CMC

Genmab

South Grafton, MA

~ 35 min OnsiteUrgently Hiring

  • Master of Science in pharmacy, engineering or equivalent
  • Proficiency in English communication (verbal and written)
  • Experience with lifecycle management
  • A track record in moving therapeutic products through various stages of development
  • Experience with leadership
  • Minimum of 10 years of industry experience within RA CMC, with a strong understanding of compliance and biologics
SmartExplore AI is experimental.
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Sterile Processing Educator

PRIDE Health

Wayland, MA

$45/hr
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