Director of Biostatistics

About the role

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 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required. 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 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, and the ability to work collaboratively across different functions in a fast-paced biotech environment.

Responsibilities

• 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

• 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 areas such as 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

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