Director of Biostatistics

The role

The Director of Biostatistics provides statistical leadership and strategic direction for clinical development programs. This person will lead multiple Phase I to IV clinical studies and provide guidance on study design, statistical analysis plans, and regulatory submission activities.

What you will do

• Lead statistical strategy for clinical development programs including study design, protocol development, and statistical analysis planning.
• Plan and track biostatistics timeline, deliverables and resources for assigned projects.
• Independently author and or review protocol, statistical analysis plans, clinical study reports, and associated publications.
• Provide statistical input for data management and programming deliverables.
• Develop statistical programs to support ad-hoc analysis requests, manuscripts and presentations.
• Provide critical statistical review of scientific reports and publications.
• Write the statistical sections of regulatory documents.
• Participate in the assessment, selection, and oversight of CROs.
• Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards.

Required 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.
• 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.
• Strong organizational and time management skills.
• Excellent communication, leadership, and analytical skills.
• Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.

Nice to have

• Experience in the area of Immunology and Inflammation is highly desirable.
• knowledge of R or similar language a plus

Benefits

• Competitive salary and benefits package.
• A chance to be part of a vibrant startup culture.
• A supportive and inclusive team environment.
• Opportunities for professional growth and development.

About the company

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company is advancing a proprietary portfolio of potentially best-in-class antibodies.