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:
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Provide statistical leadership and strategic guidance across one or more clinical development programs from protocol concept through regulatory submission and post-hoc analyses.
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Lead statistical contributions to study design, including endpoint strategy, estimands, randomization methodology, multiplicity adjustments, interim analyses, and sample size determination.
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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.
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Oversee development, validation, and review of statistical outputs, tables, listings, and figures to ensure quality, reproducibility, traceability, and regulatory compliance.
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Ensure statistical analyses and deliverables meet internal quality standards as well as applicable regulatory expectations and industry best practices.
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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.
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Lead and manage relationships with external CROs, biostatistics vendors, and programming partners, including scope definition, timelines, budget oversight, quality management, and performance monitoring.
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Support global regulatory interactions, including preparation for Health Authority meetings, submission activities, and responses to regulatory questions.
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Contribute to the development and implementation of departmental standards, processes, statistical methodologies, and operational best practices.
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Hire, mentor, coach, and develop biostatistics talent as the organization continues to scale
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Serve as a strategic thought partner to senior leadership and contribute to broader organizational and portfolio-level initiatives.
Qualifications:
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PhD or MS in Biostatistics, Statistics, or related quantitative field with significant industry experience in biotechnology or pharmaceutical drug development.
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Typically 12+ years of relevant biostatistics experience within the pharmaceutical, biotechnology, or CRO industry, including leadership responsibility supporting clinical development programs.
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Demonstrated experience supporting clinical studies across multiple phases of development, including late-stage studies and regulatory submissions.
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Deep understanding of clinical trial methodology, statistical principles, regulatory guidance, and industry standards applicable to drug development.
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Strong experience authoring and reviewing SAPs, protocols, CSRs, and regulatory submission documents.
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Hands-on experience with statistical programming environments such as R and/or SAS, including review of analysis code and outputs.
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Proven ability to effectively manage external vendors and CRO partners within a matrixed development environment.
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Experience participating in Health Authority interactions and supporting global submissions strongly preferred.
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Excellent communication, collaboration, and influencing skills with the ability to communicate complex statistical concepts to both technical and non-technical audiences.
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Demonstrated success operating in a fast-paced, highly collaborative biotech environment with evolving priorities.
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Prior people management and team development experience preferred.
Work Environment:
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 the majority of their work 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 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.
Why Join Uniquity
Uniquity Bio is a fast-paced and rapidly growing organization where ideas matter and people make the difference. The company seeks to identify leaders who are mission-driven self-starters and are comfortable working within a complex and dynamic environment.
At Uniquity, we are building a culture of curiosity, accountability, and collaboration. We are seeking leaders who are energized by growth, motivated by impact and ready to build an organization where people and science thrive together.
This role offers the opportunity to directly influence clinical development strategy and operational execution during a critical stage of company growth while helping shape the future of the Clinical Operations organization.
Work Environment
This is a small, fast-paced organization. Candidates must be self-starters who are comfortable working both independently and in collaboration with a team comprised of in-house and external team members. The ability to be productive and successful in a dynamic work environment is critical.
The position is US based. Team members who live within commuting distance to either our Malvern, PA or San Diego, CA office locations are expected to spend the majority of their work time physically present in the office interacting with other team members. Remote employees will be expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed 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.
