Director of Biostatistics

Oruka Therapeutics

. Lead statistical strategy for clinical development programs, including study design, protocol development, and statistical analysis planning .

Posted 10/2/2026full-timeUnited StatesLead💰 $213,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical methodologies for clinical trial design and analysis, with a strong focus on regulatory compliance and leadership in cross-functional team settings. Proficient in SAS programming and familiar with CDISC standards, ensuring high-quality statistical deliverables.

Highest-signal resume keywords

Ph.D. In BiostatisticsStatistical Methodologies ExpertiseSAS Programming ProficiencyFDA/EMA Regulations KnowledgeLeadership In Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlanningProtocol DevelopmentStatistical ModelingData ManagementStatistical ProgrammingClinical Trial DesignADaM RequirementsRegulatory Document WritingStatistical Report ReviewImmunology And Inflammation Experience

Soft Skills

Excellent CommunicationStrong Organizational SkillsTime ManagementAnalytical SkillsIndependent Judgment

Industry Keywords

ICH GuidelinesGCP GuidelinesCRO OversightClinical Development ProgramsBiostatistics Timelines

About the role

Key responsibilities & impact

Lead statistical strategy for clinical development programs, including study design, protocol development, and statistical analysis planning
Plan and track biostatistics timelines, deliverables, and resources for assigned projects
Proactively communicate resource needs, constraints, and risks
Independently author and/or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents
Provide statistical input for data management and programming deliverables, including data collection tools and analysis datasets
Develop statistical programs for ad-hoc analyses, manuscripts, and presentations
Critically review scientific reports and publications for appropriate and accurate data presentation
Write statistical sections of regulatory documents and collaborate with Clinical and Regulatory teams
Participate in assessment, selection, and oversight of CROs
Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards
Represent the Biostatistics function at internal and external meetings

Requirements

What you’ll need

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
Strong, up-to-date expertise/knowledge of statistical methodologies related to clinical trial design, statistical modeling and analysis
Proven capability to provide statistical leadership to cross-functional teams at the study and project level, exercise independent judgement and provide oversight to junior statisticians
Familiarity in the design, data capture, and analysis of clinical trials with potentially high placebo response
Experience in the area of Immunology and Inflammation is highly desirable
Knowledge of applicable FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements
Expertise in CDISC standards, including ADaM requirements
Advanced proficiency of the SAS programming language; knowledge of R or similar language a plus
Strong organizational and time management skills, with a demonstrated ability to prioritize multiple concurrent deliverables and ad-hoc requests
Excellent communication, leadership, and analytical skills
Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment

Benefits

Comp & perks

Equity
Performance-related bonus opportunity
Competitive salary and benefits package
Supportive and inclusive team environment
Opportunities for professional growth and development
Opportunity to work in a vibrant startup culture and directly impact bringing new medicines to patients