Associate Director, Biostatistics — Remote Impact

Oruka Therapeutics Inc; Menlo Park, Waltham (CA, MA); Hybrid; USD 182,000 - 208,000; Full time

Benefits offered by this job

Competitive salary

Equity

Bonus opportunity

Job summary

Oruka Therapeutics is hiring an Associate Director of Biostatistics to lead statistical strategy across Phase I–IV programs. You will guide study design, analysis plans, and reporting, collaborating with cross-functional teams in a fast-paced biotech setting.

The role requires a PhD in Biostatistics (or MS with extensive experience), strong SAS programming, and familiarity with FDA/EMA guidelines and CDISC standards. Hybrid work with in-office days for remote-friendly candidates is offered.

Qualifications

• Ph.D. in Biostatistics or related field with 5+ years in clinical trials, or a Masters with 8+ years.
• Strong expertise in trial design, sample size, modeling and analysis.
• Familiarity with CDISC ADaM and regulatory submission requirements.

Responsibilities

• Lead statistical execution for Phase I–IV trials and program-wide statistical strategy.
• Manage biostatistics timelines and deliverables across projects.
• Draft and review analysis plans, SAPs, CSRs and publications.
• Provide input for data management and programming deliverables to align with analyses.
• Develop statistical programs for ad-hoc analyses, manuscripts, and presentations.
• Oversee CRO biostatistics vendors and ensure timely, quality deliverables.
• Ensure compliance with ICH/GCP and regulatory standards.

Skills

Biostatistics leadership

Statistical programming

SAS

Cross-functional collaboration

Clinical trial design

FDA/EMA knowledge

Communication skills

Education

PhD in Biostatistics

MS with 8+ years experience

Tools

SAS

R

Job description

Oruka Therapeutics is hiring an Associate Director of Biostatistics to lead statistical strategy across Phase I–IV programs. You will guide study design, analysis plans, and reporting, collaborating with cross-functional teams in a fast-paced biotech setting.

The role requires a PhD in Biostatistics (or MS with extensive experience), strong SAS programming, and familiarity with FDA/EMA guidelines and CDISC standards. Hybrid work with in-office days for remote-friendly candidates is offered.