3 дня назад
Associate Director, Biostatistics (Oncology)
172 000 - 258 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Biostatistics (Oncology) (clinical trials and regulatory submissions): Leading statistical strategy, design, analysis, and reporting for Phase I–IV oncology clinical studies and integrated regulatory submissions with an accent on complex statistical methods, SAS/R programming, and CDISC standards. Focus on designing adaptive and Bayesian analyses, resolving methodological issues, supporting NDA/BLA submissions, and coordinating statisticians and external vendors.
Location: Remote/home-based for US-based candidates only; associated locations include Carlsbad, CA, Palo Alto, CA, and Philadelphia, PA.
Salary: $172,000–$258,000 annual base pay for US-based candidates, plus potential bonus, equity, and benefits.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a focus on sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
- Lead statistical strategy, study design, analysis, and reporting for Phase I–IV clinical trials and development projects.
- Develop or review statistical analysis plans, interpret clinical data, and prepare data displays.
- Create statistical programs for trial simulations, analyses, data validation, and verification of statistical programming outputs.
- Contribute to integrated reports, regulatory filings, and responses to regulatory agency questions.
- Collaborate with clinicians, data managers, statisticians, programmers, researchers, and thought leaders on clinical development and publications.
- Lead or supervise internal statisticians and manage work performed by external statistics and programming vendors.
Requirements
- PhD with more than 4 years of experience or MS with more than 6 years of experience.
- Degree in statistics, mathematics, or a related discipline with a statistical focus.
- Strong knowledge of clinical trial design, statistical inference, hypothesis testing, sample size calculations, and Phase II–IV clinical trial analysis.
- Good knowledge and experience in oncology, with expertise in drug development regulations and statistical contributions to marketing applications.
- Proficient SAS programming skills and comprehensive knowledge of CDISC SDTM and ADaM standards.
- Excellent written and verbal communication, leadership, collaboration, organization, and independent problem-solving skills.
Nice to have
- Knowledge of hematology or additional oncology experience.
- Experience with Bayesian or adaptive trial designs.
- Experience contributing to NDA or BLA submissions and defenses.
- Knowledge of additional statistical applications and programming languages.
Culture & Benefits
- Work in a fast-paced, flexible, and team-oriented environment.
- Collaborate across clinical development, research, data management, and statistical programming functions.
- Medical, dental, and vision insurance for eligible US employees.
- 401(k) retirement savings plan and flexible paid vacation.
- Potential annual cash bonus or incentive compensation and long-term equity incentives.
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