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Biostatistics Associate Director (Biotechnology)

174 800 - 262 200$
Формат работы
hybrid/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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TL;DR
Biostatistics Associate Director (Biotechnology) (clinical trials/RWD): Leading sophisticated statistical analyses and biostatistics projects for drug development with an accent on advanced methodology, Statistical Analysis Plans, and cross-functional clinical study delivery. Focus on designing study-level analyses, reviewing TFLs and programming specifications, supporting regulatory interactions, and solving complex statistical issues independently.

Location: Boston, Massachusetts, United States. Hybrid-eligible with remote work up to two days per week, or on-site five days per week with ad hoc flexibility.

Salary: $174,800–$262,200 per year, plus annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of medicines.

What you will do

  • Lead statistical work for multiple clinical trials, observational studies, and real-world data investigations.
  • Lead biostatistics projects or major project components, including work allocation and review.
  • Design and implement study- and project-level statistical methods using advanced drug-development approaches.
  • Author Statistical Analysis Plans, TFL shells, Cross-functional Data Review plans, Key Reports Memos, and Data Dissemination Plans.
  • Collaborate with statistical programming and cross-functional teams to deliver high-quality analyses, clinical study reports, publications, and posters.
  • Support interactions with regulators, payers, review boards, and internal senior review committees.

Requirements

  • Ph.D. in Statistics or Biostatistics, or an equivalent combination of education and experience.
  • Typically seven years of experience with a Ph.D.
  • In-depth competence with SAS and R statistical software.
  • In-depth understanding of advanced statistical methods used in drug development.
  • Experience with NDA/MAA submissions and direct dealings with U.S. or European regulators.
  • Strong critical thinking, problem-solving, written communication, verbal communication, and collaboration skills; prior staff management experience is typical.

Culture & Benefits

  • Hybrid or on-site work through the Flex @ Vertex program.
  • Medical, dental, and vision benefits.
  • Generous paid time off, including week-long summer and winter company shutdowns.
  • Educational assistance, student loan repayment, commuting subsidy, matching charitable donations, and 401(k).
  • Support for continuous learning in AI, technology, automation, and industry trends.

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