Senior Biostatistician

  • Contract
  • Remote

SimulStat

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Remote, 12-month contract

The Senior Biostatistician will help with ISS/ISE, SAP reviews, QA of CRO work and a general sounding board on statistical issues.

Qualifications and responsibilities

  • M.S. in Statistics, Biostatistics, or Mathematics
  • Experience needed in multiple imputation, imputation with rescue medication, analyses of data with floor effects.; ANCOVA in the presence of floor effects, PRO (patient-reported outcomes) – especially eDiary, SAP review and developments, ISS and ISE as well as NDA submission work
  • Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), and regulatory documents
  • Strong SAS programming skills including macro development and program validation
  • Oversee an FSP group of programmers working on the ISS/ISE and possibly CRO work on a Phase 3 study

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