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2 дня назад

Senior Biostatistician (IVD)

140 250 - 200 025$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
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
Senior Biostatistician (IVD): Designing and analyzing complex clinical studies for in vitro diagnostic products, supporting research, development, and regulatory submissions with an accent on clinical trial design, statistical analysis, and accurate reporting. Focus on developing protocols and statistical analysis plans, interpreting results, collaborating with statistical programmers, and preparing FDA submission materials.

Location: Remote; US target compensation range

Base salary: $140,250–$200,025 per year, plus potential equity, cash bonuses, and benefits.

Company

hirify.global develops in vitro diagnostic products focused on advancing early cancer detection.

What you will do

  • Lead biostatistical activities for high-complexity clinical studies and provide statistical oversight.
  • Develop study designs, endpoints, estimands, sample size and power calculations, and analysis methods.
  • Write statistical sections of study protocols, statistical analysis plans, and related documents.
  • Review tables, figures, listings, study reports, and regulatory documents for accurate and consistent reporting.
  • Partner with statistical programmers to manage priorities, timelines, deliverable quality, and issue resolution.
  • Support regulatory submissions, publications, presentations, and communications with internal and external stakeholders.

Requirements

  • Master’s degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science, or Mathematics.
  • 6+ years of related experience with a master’s degree, or 3+ years with a PhD, or equivalent experience.
  • Expert knowledge of biostatistical processes, clinical trial design, and methodologies for solving complex problems.
  • Strong communication, analytical, decision-making, organizational, influencing, and relationship-management skills.
  • Strong programming skills in R and proficiency with literate programming using R Markdown or Sweave.
  • Ability to work effectively in a fast-paced, changing environment and across cross-functional teams.

Nice to have

  • PhD or higher in Statistics, Biostatistics, or Mathematics.
  • Experience leading IVD clinical biostatistics through FDA submission.
  • Knowledge of CDISC requirements.
  • Python programming experience.

Culture & Benefits

  • Remote work arrangement.
  • Opportunity to contribute to early cancer detection research and development.
  • Medical, financial, and other benefits depending on the position offered.
  • Potential equity awards and cash bonuses.
  • Equal-opportunity workplace focused on diversity and non-discrimination.

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