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Principal Statistician, Raleigh, NC

Remote · Japan Full-time

About the position We are looking for a Principal Statistician who is collaborative, influential, and innovation-minded to join us in our Biometrics and Data Science team. In this global role, you’ll be a key contributor to one or more compound indications (or early development compounds) for Statistics, reporting to a (Senior) Project Lead Statistician or Senior Principal Statistician (or East Asia Lead, if applicable). You will help shape development strategy and drive the direction for quantitative analytics, innovation, and reporting, while ensuring quality-by-design and first time-right delivery of Biometrics and Data Science deliverables across programs.

Responsibilities

  • Provide statistical leadership at indication/compound level across development stages
  • Translate strategy into tactical plans, operations, and quality delivery
  • Partner with leaders on development and regulatory strategy and design
  • Be accountable for biometrics deliverables supporting project decision making
  • Drive continuous improvement and transformation of the statistics operating model
  • Represent Biometrics/Statistics internally and externally to enhance reputation Requirements
  • Master's degree
  • Minimum of 6 years pharma industry experience (4 years with PhD)
  • Clinical trial design, analysis, and reporting experience in relevant phases
  • Proficient in statistical programming (e.g., SAS or R) and simulation tools
  • Strong stakeholder skills; explain complex quantitative concepts to non-experts
  • Knowledge of CDISC standards (SDTM/ADaM); submission experience Nice-to-haves
  • PhD (preferred) in Statistics/Biostatistics (or equivalent)

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance Apply To this Job

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