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11 дней назад

Director, Biostatistics (Biopharma)

185 000 - 252 500$
Формат работы
remote (Global)
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
Director, Biostatistics (Biopharma): Leading statistical strategy, design, analysis, and reporting for clinical trials across the drug development process with an accent on advanced statistical methods, regulatory submissions, and cross-functional leadership. Focus on solving complex analytical issues, advancing innovative study designs and analytics, and guiding statistical teams through clinical development and regulatory interactions.

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with minimal travel overall.

Salary: $185,000–$252,500 annual.

Company

Global biopharmaceutical organization focused on transforming the lives of patients with serious and rare diseases.

What you will do

  • Provide statistical leadership across drug development plans, clinical studies, submission activities, and regulatory interactions.
  • Lead one or more indications and compounds in development, including the design, analysis, and reporting of clinical trials.
  • Manage timelines and oversee the quality of statistical analyses performed by CROs or internal teams.
  • Lead or contribute to statistical innovation, including innovative study design, advanced analytics, data visualization, and template development.
  • Represent Biostatistics on cross-functional teams, collaborate with key stakeholders, and lead departmental projects.
  • Provide technical guidance and mentoring to junior statisticians.

Requirements

  • PhD in Statistics or Biostatistics.
  • 8+ years of experience in the pharmaceutical industry.
  • Strong knowledge of the pharmaceutical environment and broad experience with multi-phase development.
  • Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to clinical research.
  • Strong project management, interpersonal, and communication skills.
  • A track record of successful contributions to IND and CTD submission dossiers and interactions with regulatory agencies or other external stakeholders.
  • Ability to influence and contribute to the advancement of innovative statistical methodology.

Nice to have

  • Experience with NDAs and MAAs.

Culture & Benefits

  • Fully remote work with support for purposeful in-person collaboration and flexible work schedules.
  • Medical, dental, vision, and mental health coverage, wellness reimbursement, and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, and caregiver support.
  • 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, leadership development, mentorship, networking, employee resource groups, and service opportunities.

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