Director of Biostatistics
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Oruka TherapeuticsBiotechnology, therapeutics
Location: Menlo Park, California, United States; Remote; Waltham, Massachusetts, United StatesFull-TimeDirector
Salary$213,000 to $240,000
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Job Details
- Experience
- Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of experience in clinical trials, or a Masters degree with 10+ years of experience.
- Required Skills
- R
Requirements
- Hold a Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of clinical-trial experience, or a master’s degree with 10+ years of experience.
- Bring strong, current knowledge of statistical methodologies related to clinical-trial design, statistical modeling, and analysis.
- Provide statistical leadership to cross-functional teams and oversight to junior statisticians.
- Have familiarity with the design, data capture, and analysis of clinical trials with potentially high placebo response.
- Know applicable FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements.
- Have expertise in CDISC standards, including ADaM requirements.
- Demonstrate advanced proficiency in SAS; knowledge of R or a similar language is a plus.
- Bring strong organizational and time-management skills, including the ability to prioritize concurrent deliverables and ad-hoc requests.
- Have experience in Immunology and Inflammation; this is highly desirable.
Responsibilities
- Lead statistical strategy for clinical development programs, including study design, protocol development, and statistical analysis planning.
- Plan and track biostatistics timelines, deliverables, and resources, and communicate resource needs, constraints, and risks.
- Author and review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
- Provide statistical input on data-management and programming deliverables, including data-collection tools and analysis datasets.
- Develop statistical programs for ad-hoc analyses, manuscripts, and presentations, and review scientific reports and publications.
- Write statistical sections of regulatory documents and collaborate with Clinical and Regulatory teams on regulatory strategy.
- Assess, select, and oversee CROs within the area of responsibility.
- Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards.
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