Director of Biostatistics

Oruka Therapeutics

Director of Biostatistics leading statistical strategy for clinical development at Oruka Therapeutics. Provide expert guidance on statistical analysis and collaborate across functions in a biotech environment.

Posted 5/20/2026full-timeCalifornia, Massachusetts • 🇺🇸 United StatesLead💰 $213,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

Lead statistical strategy for Oruka’s clinical development programs, including study design, protocol input, and statistical analysis planning.
Plan and track biostatistics timeline and resources for assigned projects, ensuring timeline completion of quality deliverables. Proactively communicate resource needs.
Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.
Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications, ensuring appropriate and accurate data presentation.
Write the statistical sections of regulatory documents and collaborate with Clinical and Regulatory to support Oruka’s regulatory strategy.
Participate in the assessment, selection, and oversight of CROs within area of responsibility.
Ensure compliance with company SOPs and working practices, industry and regulatory standards.

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
Up-to-date expertise/knowledge of statistical methodologies related to clinical trial design, statistical modeling and analysis
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 a plus.
Knowledge of applicable FDA regulations and ICH guidelines
Expertise in CDISC standards, including ADaM requirements
Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus.
Strong organizational and time management skills, and the ability to prioritize multiple 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

Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

biostatisticsstatistical analysisstatistical modelingSAS programmingR programmingCDISC standardsADaM requirementsclinical trial designdata managementstatistical review

Soft Skills

leadershiporganizational skillstime managementcommunication skillsanalytical skillsindependent judgementoversightcollaborationprioritizationadaptability

Certifications

Ph.D. in BiostatisticsPh.D. in StatisticsMaster's degree in related field