CAREERS

Senior Director, Biostatistics

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Location: Malvern, PA preferred
 

• Local Candidates: This role requires 2-3 days per week onsite at our Malvern or San Diego office.

• Non-Local Candidates: Candidates located outside the area (40+ miles) must be willing to travel (reimbursable expenses) to the Malvern or San Diego office 2-3 times per month for key meetings and events. 

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Job Description:

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Uniquity Bio is seeking an accomplished and driven Senior Director of Biostatistics to join our growing Clinical Development team. This critical leadership role will focus on our Respiratory and GI programs, including asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE).

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The ideal candidate will bring deep expertise in statistical strategy and analysis across Phase I–III clinical trials, providing essential insights that drive data interpretation, regulatory submissions, and program success. This is an opportunity to make a significant impact in the development of novel treatments for serious chronic conditions.

 

Key Responsibilities:​

• Lead statistical strategy and analysis planning for global clinical trials.

• Collaborate across Clinical Science, Regulatory, Programming, and Medical Writing teams.

• Design and interpret statistical models and endpoints (e.g., FEV1, exacerbation rates, DSQ).

• Contribute to regulatory submissions (INDs, NDAs, global briefing documents).

• Serve as a subject matter expert on respiratory biomarkers and lung function data modeling.

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Qualifications:

• PhD in Biostatistics, Statistics, or related quantitative field.

• 8+ years of biostatistics experience in clinical development, with strong preference for respiratory drug development.

• Proven leadership in late-stage trials and cross-functional team collaboration.

 

Required Skills, Abilities and Behaviors:

• Ability to work well with peers, the Executive Leadership Team and external audiences.

• Excellent interpersonal skills with a strong focus on collaboration.

• Ability to thrive in a fast paced, highly entrepreneurial environment.

• Excellent presentation and writing skills.