Senior Director, Biostatistics – Remote

Oruka Therapeutics Inc; Menlo Park, Waltham (CA, MA); Hybrid; USD 213,000 - 240,000; Full time

Job summary

Oruka Therapeutics seeks a Director of Biostatistics to provide statistical leadership across Phase I–IV clinical programs. You will set strategy, guide study design, SAPs, and regulatory submissions, while collaborating with cross-functional teams in a fast-paced biotech environment.

The role supports remote or hybrid work arrangements with in-office days for close collaboration in Menlo Park, CA or Waltham, MA as needed. A strong background in immunology/inflammation is highly valued.

Qualifications

• PhD with 7+ years in clinical trials or MS with 10+ years of experience.
• Strong knowledge of clinical trial design, modeling, and analysis.
• Experience leading cross-functional teams and mentoring junior statisticians.
• Familiarity with regulatory submissions and CDISC standards.

Responsibilities

• Lead statistical strategy for clinical development programs and study design.
• Plan and track biostatistics timelines, deliverables, resources.
• Independently author/review protocols and SAPs, CSRs, publications.
• Contribute statistical input for data management and analysis datasets.
• Develop programs for ad-hoc analyses, manuscripts, and presentations.
• Draft statistical sections of regulatory documents; support regulatory strategy.
• Oversee CROs and ensure compliance with ICH/GCP and SOPs.

Skills

Biostatistics leadership

Study design guidance

Cross-functional collaboration

Statistical analysis planning

Regulatory understanding

Independent judgment

Education

Ph.D. in Biostatistics or related field

MS in Biostatistics or related field

Tools

SAS

R

CDISC ADaM

Job description

Oruka Therapeutics seeks a Director of Biostatistics to provide statistical leadership across Phase I–IV clinical programs. You will set strategy, guide study design, SAPs, and regulatory submissions, while collaborating with cross-functional teams in a fast-paced biotech environment.

The role supports remote or hybrid work arrangements with in-office days for close collaboration in Menlo Park, CA or Waltham, MA as needed. A strong background in immunology/inflammation is highly valued.