Remote Director of Biostatistics - Trials Leader

Oruka Therapeutics Inc; Boston (MA); Remote; USD 213,000 - 240,000; Full time

Benefits offered by this job

Equity participation

Bonus opportunity

Job summary

Oruka Therapeutics Inc. is seeking a Director of Biostatistics to provide statistical leadership for multiple clinical development programs from Phase I to IV.

This role will lead study design, SAPs, and interpretations of trial results, and support regulatory submissions in a fast-paced biotech environment. The ideal candidate holds a PhD in Biostatistics with 7+ years of clinical trial experience or a relevant Master's with 10+ years, and excels in cross-functional collaboration, SAS/R, and

Qualifications

• Ph.D. in Biostatistics or related field with 7+ years in clinical trials.
• Strong expertise in trial design, modeling, and analysis.
• Experience leading cross-functional teams and overseeing statisticians.
• Familiarity with FDA/EMA regulations, ICH-GCP, and CDISC/ADaM.
• Immunology/inflammation experience desired.
• Excellent communication and project management skills.

Responsibilities

• Lead statistical strategy for clinical development programs across Phases I–IV.
• Plan and track biostatistics timelines, deliverables, and resources.
• Authors/reviews protocols, SAPs, CSRs, and publications.
• Provide statistical input for data management and programming deliverables.
• Develop statistical programs for ad-hoc analyses and presentations.
• Contribute to regulatory documents and regulatory strategy.

Skills

Statistical leadership

Clinical trial design

Statistical modeling

SAS

R

CDISC ADaM

FDA/EMA guidelines

Cross-functional leadership

Communication

Independent judgement

Education

PhD in Biostatistics

Masters in Biostatistics

Tools

SAS

R

Job description

Oruka Therapeutics Inc. is seeking a Director of Biostatistics to provide statistical leadership for multiple clinical development programs from Phase I to IV.

This role will lead study design, SAPs, and interpretations of trial results, and support regulatory submissions in a fast-paced biotech environment. The ideal candidate holds a PhD in Biostatistics with 7+ years of clinical trial experience or a relevant Master's with 10+ years, and excels in cross-functional collaboration, SAS/R, and