Senior Director, Biostatistics

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we're looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.


Join us in building an organization where people and science thrive together. You'll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

Position Overview

Uniquity Bio is seeking an experienced and strategic Senior Director, Biostatistics to provide statistical leadership across one or more clinical development programs within a fast-paced and highly collaborative environment. This individual will serve as a key cross-functional partner to Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and external partners to support the design, analysis, interpretation, and reporting of clinical studies.

The Senior Director will play a critical role in advancing programs from early development through late-stage clinical execution and regulatory submission activities. The ideal candidate combines strong technical expertise with strategic thinking, operational excellence, and the ability to influence across multidisciplinary teams.

This role requires a hands-on leader who is comfortable operating both strategically and tactically within a growing biotechnology organization.

Key Responsibilities

• Provide statistical leadership and strategic guidance across one or more clinical development programs from protocol concept through regulatory submission and post-hoc analyses
• Lead statistical contributions to study design, including endpoint strategy, estimands, randomization methodology, multiplicity adjustments, interim analyses, and sample size determination
• Author, review, and approve statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), regulatory briefing documents, publications, and other study-related deliverables
• Oversee development, validation, and review of statistical outputs, tables, listings, and figures to ensure quality, reproducibility, traceability, and regulatory compliance
• Ensure statistical analyses and deliverables meet internal quality standards as well as applicable regulatory expectations and industry best practices
• Partner closely with cross-functional study teams to support data review, interpretation of study results, risk assessment, and decision-making throughout the clinical development lifecycle
• Lead and manage relationships with external CROs, biostatistics vendors, and programming partners, including scope definition, timelines, budget oversight, quality management, and performance monitoring
• Support global regulatory interactions, including preparation for Health Authority meetings, submission activities, and responses to regulatory questions
• Contribute to the development and implementation of departmental standards, processes, statistical methodologies, and operational best practices
• Hire, mentor, coach, and develop biostatistics talent as the organization continues to scale
• Serve as a strategic thought partner to senior leadership and contribute to broader organizational and portfolio-level initiatives

Qualifications

• PhD or MS in Biostatistics, Statistics, or related quantitative field with significant industry experience in biotechnology or pharmaceutical drug development
• Typically 12+ years of relevant biostatistics experience within the pharmaceutical, biotechnology, or CRO industry, including leadership responsibility supporting clinical development programs
• Demonstrated experience supporting clinical studies across multiple phases of development, including late-stage studies and regulatory submissions
• Deep understanding of clinical trial methodology, statistical principles, regulatory guidance, and industry standards applicable to drug development
• Strong experience authoring and reviewing SAPs, protocols, CSRs, and regulatory submission documents
• Hands-on experience with statistical programming environments such as R and/or SAS, including review of analysis code and outputs
• Proven ability to effectively manage external vendors and CRO partners within a matrixed development environment
• Experience participating in Health Authority interactions and supporting global submissions strongly preferred
• Excellent communication, collaboration, and influencing skills with the ability to communicate complex statistical concepts to both technical and non-technical audiences
• Demonstrated success operating in a fast-paced, highly collaborative biotech environment with evolving priorities
• Prior people management and team development experience preferred

Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.


This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee's manager. Business travel may be required depending upon the specific needs of the position.


The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.