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9 дней назад

Associate Director, Biostatistics (Late Stage Oncology)

175 440 - 263 160$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Japan
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Director, Biostatistics (Late Stage Oncology) (Biostatistics/Oncology): Leading complex late-stage clinical studies, from study design and statistical analysis through results interpretation and clinical study report development, with an accent on drug development strategy, regulatory submissions, and CRO oversight. Focus on designing scientifically sound studies, validating analysis deliverables, guiding statistical teams, and solving complex problems in global health authority interactions.

Location: Basking Ridge, New Jersey, United States; ability to travel up to 10% of the time

Salary: USD $175,440–$263,160 per year

Company

hirify.global develops innovative pharmaceutical therapies, with a primary focus on oncology, cardiovascular disease, rare diseases, and immune disorders.

What you will do

  • Lead statistical activities for complex clinical studies, including study design, protocol development, CRF review, SAP development, analysis files, validation, results interpretation, and CSR input.
  • Serve as the primary statistical contact for assigned studies and projects and advise study teams on statistical activities.
  • Contribute to drug development plans, ensuring scientifically sound designs, regulatory compliance, and alignment with the intended product profile.
  • Oversee CRO and vendor proposals, budgets, deliverables, timelines, statistical programming, and analysis quality.
  • Contribute to global Health Authority submissions, meetings, teleconferences, and interaction documents.
  • Participate in initiatives improving the harmonization, efficiency, cost, and timelines of drug development.

Requirements

  • Master’s degree in statistics or biostatistics required.
  • 8+ years of relevant pharmaceutical industry experience with a master’s degree.
  • Experience leading complex clinical studies and statistical analyses.
  • Ability to collaborate with study teams, data managers, CRO biostatisticians, and statistical programmers.
  • Ability to travel up to 10% of the time.

Nice to have

  • PhD in statistics or biostatistics.
  • 5+ years of relevant pharmaceutical industry experience with a PhD.

Culture & Benefits

  • Work within a global pharmaceutical organization focused on innovative medicines and oncology.
  • Collaborate with international study teams, CROs, vendors, and Health Authorities.
  • Equal opportunity and affirmative action employment environment.

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