Director of Biostatistics

Oruka Therapeutics Inc; Boston (MA); Remote; USD 213,000 - 240,000; Full time

Benefits offered by this job

Equity participation

Bonus opportunity

Job summary

Oruka Therapeutics Inc. is seeking a Director of Biostatistics to provide statistical leadership for multiple clinical development programs from Phase I to IV.

This role will lead study design, SAPs, and interpretations of trial results, and support regulatory submissions in a fast-paced biotech environment. The ideal candidate holds a PhD in Biostatistics with 7+ years of clinical trial experience or a relevant Master's with 10+ years, and excels in cross-functional collaboration, SAS/R, and

Qualifications

• Ph.D. in Biostatistics or related field with 7+ years in clinical trials.
• Strong expertise in trial design, modeling, and analysis.
• Experience leading cross-functional teams and overseeing statisticians.
• Familiarity with FDA/EMA regulations, ICH-GCP, and CDISC/ADaM.
• Immunology/inflammation experience desired.
• Excellent communication and project management skills.

Responsibilities

• Lead statistical strategy for clinical development programs across Phases I–IV.
• Plan and track biostatistics timelines, deliverables, and resources.
• Authors/reviews protocols, SAPs, CSRs, and publications.
• Provide statistical input for data management and programming deliverables.
• Develop statistical programs for ad-hoc analyses and presentations.
• Contribute to regulatory documents and regulatory strategy.

Skills

Statistical leadership

Clinical trial design

Statistical modeling

SAS

R

CDISC ADaM

FDA/EMA guidelines

Cross-functional leadership

Communication

Independent judgement

Education

PhD in Biostatistics

Masters in Biostatistics

Tools

SAS

R

Job description

Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Director of Biostatistics

Location: Remote or Hybrid, with 2-3 days in the office if within commuting distance of Menlo Park, CA or Waltham, MA

Role Overview:

The Director of Biostatistics will provide statistical leadership and strategic direction for our clinical development programs. This individual will serve as the lead biostatistician for multiple Phase I to IV clinical studies and will be responsible for providing expert guidance on study design, statistical analysis plans, and the interpretation of clinical trial results as well as statistical support for regulatory submission activities. The candidate will represent the Biostatistics function at internal and external meetings. The ideal candidate will bring a strong foundation in statistical methodology, curiosity for staying informed on advances in statistics, proficiency in statistical programming languages, independence in managing project deliverables, and the ability to work collaboratively across different functions in a fast-paced biotech environment.

Key Responsibilities:

• Lead statistical strategy for Oruka’s clinical development programs, including study design, protocol development, and statistical analysis planning, while collaborating closely with cross-functional study teams.
• Plan and track biostatistics timeline, deliverables and resources for assigned projects, ensuring timeline completion of quality deliverables while proactively communicating resource needs, constraints and risks.
• Independently authors and/or reviews protocol, statistical analysis plans, clinical study reports, associated publications, and other study level documents.
• Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure alignment with protocol objectives and statistical analyses.
• Develop statistical programs to support ad-hoc analysis requests, manuscripts and presentations. Provide critical 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, ICH and GCP guidelines, and regulatory standards.

Qualifications:

• 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 areas such as 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.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, $213,000 to $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role

$213,000 - $240,000 USD

What We Offer:

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

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.