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3 дня назад

Associate Director, Biostatistics (Oncology)

172 000 - 258 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US/Ireland
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 (Oncology) (clinical trials and regulatory submissions): Leading statistical strategy, design, analysis, and reporting for Phase I–IV oncology clinical studies and integrated regulatory submissions with an accent on complex statistical methods, SAS/R programming, and CDISC standards. Focus on designing adaptive and Bayesian analyses, resolving methodological issues, supporting NDA/BLA submissions, and coordinating statisticians and external vendors.

Location: Remote/home-based for US-based candidates only; associated locations include Carlsbad, CA, Palo Alto, CA, and Philadelphia, PA.

Salary: $172,000–$258,000 annual base pay for US-based candidates, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on sleep disorders, epilepsy, oncology, and neuroscience.

What you will do

  • Lead statistical strategy, study design, analysis, and reporting for Phase I–IV clinical trials and development projects.
  • Develop or review statistical analysis plans, interpret clinical data, and prepare data displays.
  • Create statistical programs for trial simulations, analyses, data validation, and verification of statistical programming outputs.
  • Contribute to integrated reports, regulatory filings, and responses to regulatory agency questions.
  • Collaborate with clinicians, data managers, statisticians, programmers, researchers, and thought leaders on clinical development and publications.
  • Lead or supervise internal statisticians and manage work performed by external statistics and programming vendors.

Requirements

  • PhD with more than 4 years of experience or MS with more than 6 years of experience.
  • Degree in statistics, mathematics, or a related discipline with a statistical focus.
  • Strong knowledge of clinical trial design, statistical inference, hypothesis testing, sample size calculations, and Phase II–IV clinical trial analysis.
  • Good knowledge and experience in oncology, with expertise in drug development regulations and statistical contributions to marketing applications.
  • Proficient SAS programming skills and comprehensive knowledge of CDISC SDTM and ADaM standards.
  • Excellent written and verbal communication, leadership, collaboration, organization, and independent problem-solving skills.

Nice to have

  • Knowledge of hematology or additional oncology experience.
  • Experience with Bayesian or adaptive trial designs.
  • Experience contributing to NDA or BLA submissions and defenses.
  • Knowledge of additional statistical applications and programming languages.

Culture & Benefits

  • Work in a fast-paced, flexible, and team-oriented environment.
  • Collaborate across clinical development, research, data management, and statistical programming functions.
  • Medical, dental, and vision insurance for eligible US employees.
  • 401(k) retirement savings plan and flexible paid vacation.
  • Potential annual cash bonus or incentive compensation and long-term equity incentives.

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