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7 часов назад

Associate Director, Biostatistics (Oncology)

193 500 - 250 500$
Формат работы
remote (только USA)/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 Director, Biostatistics (Oncology): Providing statistical leadership and support for oncology clinical trials, including protocol design, statistical analysis plans, efficacy and safety analyses, and regulatory submissions with an accent on advanced study design, clinical trial methodology, and data standards. Focus on leading multiple studies, validating SAS analyses, guiding CRO and biometrics activities, and supporting NDA/BLA and clinical study report development.

Location: Woburn, United States, or remote within the United States. Remote candidates living more than 65 miles from the Woburn headquarters must be available to travel to the office 15–25% of the time, approximately every 4–6 weeks or as business needs require.

Salary: $193,500–$250,500 annual base pay, plus performance incentive bonus, new-hire equity, and ongoing performance-based equity.

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies through its proprietary RPx platform to stimulate local and systemic anti-tumor immune responses.

What you will do

  • Provide statistical support for clinical development plans and assigned oncology clinical trials.
  • Contribute statistical input to protocols and develop statistical analysis plans, tables, listings, and figures.
  • Lead biostatistics activities for assigned clinical studies, publications, and conference presentations.
  • Support database monitoring and lock activities, clinical study reports, and publications.
  • Monitor internal biometrics and CRO activities, including timelines, deliverables, and resources.
  • Participate in pre-IND and NDA/BLA activities, develop department standards, and lead process improvements.

Requirements

  • PhD or MS in Biostatistics or Statistics.
  • At least 3 years of pharmaceutical or biotechnology industry experience with a PhD, or 5 years with an MS.
  • Advanced study design and current biostatistical methodology knowledge.
  • Independent statistician experience with responsibility for multiple studies or projects.
  • Good knowledge of statistical programming languages, including SAS, and of SDTM/ADaM.
  • Strong interpersonal, leadership, communication, independent-working, and collaboration skills.

Nice to have

  • Oncology clinical trial experience, especially in solid tumors.
  • Experience with NDA/BLA eCTDs or other global regulatory submissions.

Culture & Benefits

  • Mission-driven work focused on transforming cancer treatment and improving patient outcomes.
  • Medical, dental, and vision insurance.
  • 401(k) matching, flexible time off, and paid holidays including a year-end shutdown.
  • Annual performance incentive bonus and equity opportunities.

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