Associate Director, Biostatistics
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Oruka TherapeuticsBiopharmaceuticals
Remote or Hybrid, with 2-3 days in the office if within commuting distance of Menlo Park, CA or Waltham, MAFull-TimeDirector
SalaryThe anticipated salary range for candidates, $182,000 to $208,000.
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Job Details
- Experience
- Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of experience in clinical trials, or a Masters degree with 8+ years of experience.
- Required Skills
- R
Requirements
- Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of clinical-trial experience, or a master’s degree with 8+ years of experience.
- Strong, current knowledge of statistical methodologies for clinical-trial design, sample-size determination, statistical modeling, and analysis.
- Ability to provide statistical leadership and guidance to cross-functional teams at study and project level and exercise independent judgment.
- Familiarity with the design, data capture, and analysis of clinical trials with potentially high placebo response.
- Knowledge of applicable FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements.
- Expertise in CDISC standards, including ADaM requirements.
- Advanced proficiency in SAS; knowledge of R or a similar language is a plus.
- Strong organizational and time-management skills, including prioritizing concurrent deliverables and ad-hoc requests.
- Experience in Immunology and Inflammation is highly desirable.
Responsibilities
- Drive statistical execution for assigned programs, including input on study design, protocol development, and statistical analysis planning.
- Manage biostatistics timelines and deliverables, and communicate resource constraints and risks.
- Author and critically review protocol statistical sections, statistical analysis plans, clinical study reports, publications, and other study 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.
- Review scientific reports and publications for appropriate and accurate data presentation.
- Oversee CRO biostatistics vendors, managing timelines and deliverables and ensuring quality.
- Ensure compliance with company SOPs and working practices, ICH and GCP guidelines, and regulatory standards.
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