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5 дней назад

Manager, Biostatistics (Clinical Trials)

146 540 - 189 640$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Manager, Biostatistics (Clinical Trials): Providing statistical guidance for translational drug development programs, clinical trial endpoints, PK/PD analyses, and regulatory submissions with an accent on advanced statistical methodologies, biomarker analysis, and predictive modeling. Focus on designing analysis plans, advising cross-functional research teams, overseeing vendor deliverables, and developing statistical workflows with SAS, R, machine learning, and bioinformatics.

Location: Foster City, California, United States

Salary: $146,540–$189,640 per year, with potential annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and T-cell receptor engineered therapies.

What you will do

  • Provide statistical guidance for translational drug development programs, study design, and advanced analyses.
  • Develop and review translational statistical analysis plans, derived variables, analysis datasets, statistical methods, and PK/PD reporting materials.
  • Support NDA, BLA, and other regulatory submissions to the FDA, EMA, and global regulatory agencies.
  • Design and execute analyses for clinical, translational, exploratory, and biomarker endpoints with scientists and clinicians.
  • Advise teams on statistical, machine learning, bioinformatics, and multivariable predictive modeling methodologies.
  • Manage project resources and vendors, review deliverables, and maintain cross-functional working relationships.

Requirements

  • 6+ years of relevant experience with a BS/BA in Biostatistics, Statistics, or a related quantitative discipline, or 4+ years with an MS.
  • Strong knowledge of clinical trial design, drug development, regulatory principles, and exploratory analyses in immuno-oncology.
  • Expertise in statistical methodologies and industry practices for drug development.
  • Ability to work independently, collaborate across functions, and explain advanced statistical methods clearly.
  • Strong proficiency in SAS and/or R.

Nice to have

  • PhD in Biostatistics, Statistics, or a related quantitative discipline with 2+ years of relevant experience.
  • Knowledge of pharmacokinetics and pharmacodynamics.
  • Experience developing tools or AI agents for statistical analysis or workflows.

Culture & Benefits

  • Mission-driven work focused on developing durable cancer treatments.
  • Medical, dental, vision, and life insurance plans.
  • Paid time off and potential discretionary bonus and stock-based long-term incentives.
  • Inclusive work environment that supports diverse perspectives and individual differences.

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