Remote Senior Biostatistics Lead for Clinical Trials

Oruka Therapeutics Inc; Boston (MA); Hybrid; USD 182,000 - 208,000; Full time

Benefits offered by this job

Competitive base salary

Equity

Bonus opportunity

Job summary

Oruka Therapeutics Inc. is seeking an Associate Director of Biostatistics to lead statistical strategy and execution across multiple clinical trials.

You will supervise study design, SAPs, and reporting, while coordinating with cross-functional teams in a fast-paced biotech setting. The role requires a PhD in Biostatistics (or MS with extensive experience) and strong SAS/R skills, with a focus on regulatory standards and data quality.

Qualifications

• Ph.D. in Biostatistics, Statistics, or related field with 5+ years in clinical trials, or MS with 8+ years.
• Expertise in study design, sample size, modeling, and analysis for trials.
• Ability to lead cross-functional teams and exercise independent judgment.
• Experience with FDA/EMA, ICH-GCP, and CDISC ADaM standards.
• Strong programming skills and ability to guide data management and programming.
• Experience with immunology/inflammation is desirable.

Responsibilities

• Provide statistical leadership for Phase I–IV programs and trials.
• Lead protocol sections, SAPs, and reports with independence.
• Develop statistical programs for ad-hoc analyses and reviews.
• Oversee CRO biostatistics vendors and manage timelines.

Skills

Biostatistics

Clinical trials

Statistical programming

SAS

R

Leadership

GCP/ICH

Cross-functional

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Job description

Oruka Therapeutics Inc. is seeking an Associate Director of Biostatistics to lead statistical strategy and execution across multiple clinical trials.

You will supervise study design, SAPs, and reporting, while coordinating with cross-functional teams in a fast-paced biotech setting. The role requires a PhD in Biostatistics (or MS with extensive experience) and strong SAS/R skills, with a focus on regulatory standards and data quality.