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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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