23 часа назад
Senior Manager, Biostatistics
169 320 - 219 120$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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