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Provide statistical leadership and strategic guidance for clinical development programs from protocol concept through regulatory submission. Lead the design, analysis, and reporting of clinical studies while managing external CROs and mentoring internal talent.
Requires a PhD or MS in Biostatistics or a related field with over 12 years of industry experience in drug development. Must have a proven track record of supporting late-stage clinical studies and interacting with global health authorities.
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
Qualifications
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.
Where scientific innovation and start-up agility meet
At Uniquity Bio, we bring decades of experience from the world’s top pharmaceutical companies and research institutions into the rigorous — yet nimble — development of exciting, high-potential medicines.
