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Biostatistics Director

2 months ago

Redwood City, California, United States Meet Full time
Job Title: Director Biostatistics

Meet is dedicated to creating innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, our teams worldwide leverage our legacy of innovation and robust pipeline of promising new medicines to help people.

Job Summary

The Director Biostatistics will lead complex studies in study design, statistical analysis, and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.

Key Responsibilities

  • Protocol Development and Statistical Analysis: Leads statistical activities for complex studies, including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation, and CSR input and review.
  • Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements, and deliver the pre-specified product profile.
  • CRO/Vendor Oversight: Reviews CRO/vendor proposal and budget, establishes procedures through regular interaction, sets expectations on deliverables and timelines, and guides CRO biostatistician and statistical programmers on complex studies.
  • Global Health Authority Interaction/Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document.
  • Global BDO Strategy to Improve Drug Development: Participates and may occasionally lead moderately complex initiatives to improve the harmonization and efficiency of drug development, leading to cost savings and shortened timelines for the company.

Qualifications

Successful candidates will meet the qualifications below with or without a reasonable accommodation.

Education Qualifications

  • MS in statistics or biostatistics is required; PhD in statistics or biostatistics is preferred.
  • 2 years of Oncology trial support experience required.