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5 дней назад

Associate Biostatistics Director (Biotech)

166 500 - 236 500$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
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 Biostatistics Director (Biotech): Designing and analyzing clinical trials across phases, developing statistical analysis plans, and overseeing ADaM and TLF programming with an accent on oncology studies, regulatory compliance, and CRO management. Focus on interpreting efficacy results, validating key endpoint analyses, and coordinating complex statistical deliverables across multidisciplinary clinical teams.

Location: Alameda, California, United States

Base salary: $166,500–$236,500 annually, adjusted according to geographic market, qualifications, experience, and internal equity.

Company

hirify.global is a biotechnology and pharmaceutical company developing oncology treatments and conducting clinical research.

What you will do

  • Provide statistical recommendations and support the design, conduct, and analysis of clinical trials across Phases I–III.
  • Contribute to clinical protocol development, review CRFs and edit checks, and author statistical analysis plans, TLF shells, and output specifications.
  • Analyze and interpret study results and collaborate on interim reports, final reports, and publications.
  • Manage CRO deliverables and oversee programming of ADaMs and TLFs within agreed timelines and budgets.
  • Validate and perform quality control of key endpoint analyses and regulatory submission deliverables.
  • Collaborate with clinicians, data managers, statistical programmers, medical writers, and other clinical development partners.

Requirements

  • MS/MA degree in a related discipline with at least 9 years of relevant experience, or a PhD with at least 5 years of relevant experience; equivalent education and experience may be considered.
  • Strong knowledge of biostatistical methods, clinical data management procedures, statistical applications, and applicable regulations and industry standards.
  • Strong SAS programming knowledge and experience developing or reviewing SDTM and ADaM specifications.
  • Experience managing CROs during clinical trial execution and representing Biostatistics and Clinical Data Management in multidisciplinary meetings.
  • Ability to lead major programs or functions, guide teams, and develop solutions to complex statistical and business problems.

Nice to have

  • Oncology experience and experience with clinical studies across Phases I–III.
  • Biotechnology or pharmaceutical industry experience.
  • Certification in the assigned area.

Culture & Benefits

  • Comprehensive employee benefits package with 401(k) contributions.
  • Medical, dental, vision, life, disability, and flexible spending account coverage.
  • Eligibility for a discretionary annual bonus, company stock purchase, and long-term incentives.
  • 15 accrued vacation days during the first year, 17 paid holidays, and a company-wide winter shutdown.
  • Up to 10 sick days per calendar year.

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