data visualizationstatisticsclinical researchadvanced analyticsbiostatisticsclinical trialsregulatory submissionspharmaceutical development
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Чёткая зона ответственности на уровне директора, высокая зарплатная вилка и удалённый формат делают вакансию сильной возможностью для опытного специалиста, хотя роль включает широкий круг клинических и регуляторных задач.
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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