Senior Biostatistics Director - Clinical Trials (Remote/Hybrid)

Oruka Therapeutics Inc; Boston (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Oruka is seeking a Lead of Statistical Strategy to steer clinical development from Phase I to IV for biologics addressing dermatologic and inflammatory diseases. The role requires leading study design, analysis planning, and regulatory documentation in a global program.

The candidate will oversee data management integration, collaborate with CROs, and ensure compliance with GxP standards while guiding cross-functional teams across trials in immunology-focused areas.

Qualifications

• PhD in Biostatistics or related field with 7+ years (or a Master’s with 10+ years) experience.
• Expertise in clinical trial design, statistical modeling, and analysis.
• SAS proficiency; knowledge of R beneficial; familiarity with FDA/EMA, ICH-GCP, CDISC.

Responsibilities

• Oversee study design, develop statistical analysis plans, author key documents, support data management and regulatory submissions, and manage CRO oversight.

Skills

Clinical trial design

Statistical modeling

SAS

R programming

Leadership

Communication

Regulatory knowledge

GxP compliance

Education

PhD in Biostatistics or related field

Master's in Biostatistics (alternative path)

Tools

SAS

R

Job description

Oruka is seeking a Lead of Statistical Strategy to steer clinical development from Phase I to IV for biologics addressing dermatologic and inflammatory diseases. The role requires leading study design, analysis planning, and regulatory documentation in a global program.

The candidate will oversee data management integration, collaborate with CROs, and ensure compliance with GxP standards while guiding cross-functional teams across trials in immunology-focused areas.