Назад
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23 часа назад

Senior Manager, Biostatistics

169 320 - 219 120$
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
Senior Manager, Biostatistics (Biostatistics/Cell Therapy): Providing statistical leadership for clinical trials and real-world evidence generation across CAR T and next-generation cellular therapy programs with an accent on study design, regulatory support, and oncology data analysis. Focus on developing statistical analysis plans, interpreting clinical and real-world data, supporting regulatory submissions, and mentoring biostatistics team members.

Location: Foster City, California, United States

Salary: $169,320–$219,120 per year, plus 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 TCR-engineered cell therapies.

What you will do

  • Provide statistical leadership across clinical trials and evidence-generation activities for CAR T and next-generation cellular therapy programs.
  • Lead protocol development, endpoint selection, sample size determination, statistical analysis plans, interim analyses, ad hoc analyses, and interpretation of results.
  • Support regulatory submissions, health authority interactions, clinical study reports, and other development documentation.
  • Contribute to publications, congress presentations, post-hoc analyses, and real-world evidence initiatives.
  • Represent Biostatistics in governance and development forums, ensuring scientific rigor, regulatory compliance, and reproducibility.
  • Mentor junior team members and provide technical guidance on evolving statistical methodology and regulatory guidance.

Requirements

  • PhD or PharmD.
  • Strong knowledge of biostatistical principles and clinical trial methodology in the pharmaceutical or biotechnology industry.
  • Experience analyzing clinical trial and real-world data, including claims data, electronic health records, registries, natural history studies, and external control arms.
  • Proficiency in statistical programming using SAS and R.
  • Experience supporting regulatory submissions, health authority interactions, advisory committee preparation, or post-marketing commitments.
  • Strong communication and organizational skills, with the ability to explain quantitative findings and influence decisions in a matrix environment.

Nice to have

  • Experience in hematology, oncology, immuno-oncology, cell therapy, gene therapy, or other advanced therapeutic modalities.
  • Prior experience supporting CAR T-cell or other immune-cell therapy programs.
  • Knowledge of Bayesian methods, causal inference, adaptive designs, propensity score methods, multiple imputation, and survival modeling.

Culture & Benefits

  • Work alongside cross-functional partners in Real-World Evidence, Statistical Programming, Clinical Operations, Data Management, Regulatory Affairs, and Translational Medicine.
  • Focus on inclusion, talent development, employee empowerment, and diverse perspectives.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
  • Paid time off and potential discretionary bonus and stock-based long-term incentives are available, subject to eligibility.

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