Associate Director – Biostatistics

Oruka Therapeutics

. Drive statistical execution for assigned programs, contributing to study design, protocol development, and statistical analysis planning .

Posted 10/2/2026full-timeUnited StatesSenior💰 $182,000 - $208,000 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 compliance with FDA/EMA regulations and ICH-GCP guidelines. Proven ability to lead cross-functional teams and manage biostatistics deliverables effectively in a fast-paced environment.

Highest-signal resume keywords

Ph.D. In BiostatisticsStatistical Methodologies ExpertiseSAS ProficiencyCDISC Standards KnowledgeStatistical Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlanningProtocol DevelopmentSample Size DeterminationStatistical ModelingAd-Hoc Analysis DevelopmentData ManagementClinical Study Report AuthoringStatistical ProgrammingStatistical ReviewClinical Trials Experience

Soft Skills

Excellent CommunicationLeadership SkillsOrganizational SkillsTime ManagementAnalytical Skills

Tools & Technologies

SASRData Collection ToolsStatistical Software

Industry Keywords

Clinical TrialsImmunologyInflammationFDA RegulationsEMA RegulationsICH-GCP GuidelinesCDISC StandardsStatistical Submission Requirements

About the role

Key responsibilities & impact

Drive statistical execution for assigned programs, contributing to study design, protocol development, and statistical analysis planning
Manage biostatistics timelines and deliverables, communicating resource constraints and risks
Author and critically review protocol statistical sections, 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
Review scientific reports and publications for accurate and appropriate data presentation
Oversee CRO biostatistics vendors, including timelines and deliverables
Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards
Serve as lead biostatistician for multiple Phase I to IV clinical studies and provide statistical leadership for clinical development programs

Requirements

What you’ll need

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
Strong, up-to-date expertise in statistical methodologies related to clinical trial design, sample size determination, statistical modeling, and analysis
Proven capability to provide statistical leadership and guidance to cross-functional teams and exercise independent judgement
Familiarity with the design, data capture, and analysis of clinical trials with potentially high placebo response
Experience in 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 in SAS; knowledge of R or similar language a plus
Strong organizational and time management skills, with ability to prioritize multiple concurrent deliverables and ad-hoc requests
Excellent communication, leadership, and analytical skills
Ability to work effectively in a dynamic, cross-functional, and fast-paced team environment

Benefits

Comp & perks

Competitive salary and benefits package
Equity
Performance-related bonus opportunity
Supportive and inclusive team environment
Opportunities for professional growth and development
Vibrant startup culture with direct impact on bringing new medicines to patients