Director of Biostatistics

Oruka Therapeutics•Waltham, CA

12d•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming to provide patients with significant freedom from their conditions. The company is building its core team and seeking passionate individuals to contribute to establishing an engaged, inclusive, and positive company culture. The Director of Biostatistics will provide statistical leadership and strategic direction for clinical development programs, serving as the lead biostatistician for multiple clinical studies. This role involves guiding study design, statistical analysis plans, interpreting results, and supporting regulatory submissions. The ideal candidate will possess strong statistical methodology, stay updated on statistical advancements, be proficient in programming languages, manage project deliverables independently, and collaborate effectively in a fast-paced biotech environment.

Requirements

Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of experience in clinical trials, or a Masters degree with 10+ years of experience.
Strong, up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis.
Proven capability to provide statistical leadership to cross-functional teams at the study and project level, exercise independent judgement and provide oversight to junior statisticians
Familiarity in the design, data capture, and analysis of clinical trials with potentially high placebo response
Knowledge of applicable FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements.
Expertise in CDISC standards, including ADaM requirements
Advanced proficiency of the SAS programming language; knowledge of R or similar language a plus.
Strong organizational and time management skills, with a demonstrated ability to prioritize multiple concurrent deliverables and ad-hoc requests.
Excellent communication, leadership, and analytical skills.
Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.

Nice To Haves

Experience in the area of Immunology and Inflammation is highly desirable.

Responsibilities

Lead statistical strategy for Oruka’s clinical development programs, including study design, protocol development, and statistical analysis planning, while collaborating closely with cross-functional study teams.
Plan and track biostatistics timeline, deliverables and resources for assigned projects, ensuring timeline completion of quality deliverables while proactively communicating resource needs, constraints and risks.
Independently authors and/or reviews protocol, statistical analysis plans, clinical study reports, associated publications, and other study level documents.
Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure alignment with protocol objectives and statistical analyses.
Develop statistical programs to support ad-hoc analysis requests, manuscripts and presentations.
Provide critical statistical review of scientific reports and publications, ensuring appropriate and accurate data presentation.
Write the statistical sections of regulatory documents and collaborate with Clinical and Regulatory to support Oruka’s regulatory strategy.
Participate in the assessment, selection, and oversight of CROs within area of responsibility.
Ensure compliance with company SOPs and working practices, ICH and GCP guidelines, and regulatory standards.