Director of Biostatistics

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.

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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,…