5 дней назад
Executive Director, Biostatistics (Oncology)
271 000 - 385 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Director, Biostatistics (Oncology): Leading statistical strategy, design, and analysis for Phase I–IV oncology clinical trials across multiple compounds with an accent on regulatory compliance, trial methodology, and biostatistics standards. Focus on directing complex study analyses, supervising statisticians, managing CRO deliverables and budgets, and engaging with FDA and EU authorities.
Location: Alameda, California, United States; office-based working conditions
Salary: $271,000–$385,000 annually, varying by U.S. geographic market
Company
develops oncology medicines and conducts clinical development programs across multiple compounds.
What you will do
- Lead statistical strategy, trial design, conduct, and analysis for Phase I–IV clinical studies, particularly oncology programs.
- Review protocols, case report forms, statistical analysis plans, and clinical study results.
- Direct interim and final reports, safety updates, publications, and statistical support for NDAs.
- Set biostatistics department standards, policies, practices, and process-improvement initiatives.
- Supervise and develop biostatisticians while providing guidance across related functions.
- Manage CROs and other vendors, including proposals, scopes of work, timelines, deliverables, budgets, and contract negotiations.
Requirements
- MS/MA in Statistics, Biostatistics, or a related discipline with at least 16 years of relevant experience, or a PhD with at least 15 years of relevant experience.
- At least 5 years managing oncology clinical trials and 10+ years across other therapeutic areas.
- Experience supervising multiple statisticians and leading Phase I–IV oncology studies, preferably Phase III.
- In-depth knowledge of FDA, EMA, and ICH guidelines, clinical trial methodology, CDISC standards, and SDTM/ADaM specifications.
- Experience with statistical software such as SAS, EAST, nQuery, or Cytel Studio.
- Strong people management, communication, conflict management, analytical, project management, and vendor negotiation skills.
Culture & Benefits
- Collaborative office environment focused on sharing ideas and solutions.
- Equipment provided, including dual monitors and ergonomic chairs.
- 401(k) plan with company contributions, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- Annual discretionary bonus eligibility, company stock purchase opportunities, and long-term incentives.
- Fifteen vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.
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