5 дней назад
Manager, Biostatistics (Clinical Trials)
146 540 - 189 640$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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