Associate Director, Biostatistics

uniQure; Lexington (MA); On-site; USD 188,000 - 228,000; Full time

Job summary

uniQure seeks an Associate Director of Biostatistics in Lexington, MA to provide study-level statistical leadership across all clinical development phases, oversee CRO biometrics, and partner with cross-functional teams to deliver rigorous analyses and regulatory documents.

Reporting to the Senior Director of Biostatistics, you will design studies, develop SAPs, review CSR tables/ADaM, and ensure timely, high-quality scientific outputs while mentoring junior staff in a fast-paced environment.

Qualifications

• PhD in Biostatistics, Statistics, or a related field is required.
• 3+ years biostatistics experience in analyzing clinical trial data.

Responsibilities

• Collaborate with cross-functional teams on study design, protocol development, CSR, and regulatory submissions.
• Review Tables, Listings, Figures (TLFs) and ADaM specifications.
• Conduct literature reviews and evaluate statistical methodologies for clinical data analysis.
• Lead CRO biometrics activities and manage contractors to ensure quality deliverables.
• Develop TLF shells and ADaM specs for ad hoc and post-hoc analyses.
• Communicate complex statistics to diverse audiences in written and verbal form.
• Contribute to Biostatistics SOPs and standards.
• Perform clinical trial simulations to inform study design.

Skills

Biostatistics

Clinical trial analysis

Study design

R programming

SAS programming

Regulatory submissions

Education

PhD in Biostatistics, Statistics, or related field

Tools

SAS

R

Job description

Place in the Organization

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Reporting to the Senior Director of Biostatistics, the Associate Director, Biostatistics will serve as the study-level statistical subject matter expert (SME) for assigned clinical programs. This role is responsible for providing strategic and technical statistical support across all phases of clinical development, including study design, statistical analysis plan development, regulatory document preparation, and the review and interpretation of clinical trial data.

The Associate Director will join an established biometrics organization consisting of both an internal team based in Lexington, MA, and external consultants with extensive clinical development expertise. This position requires close collaboration with Statistical Programming, Clinical Operations, Medical, Regulatory, and other key functional areas within a dynamic and fast-paced cross-functional environment.

The ideal candidate will partner closely with study teams to provide statistical leadership, contribute to study-level development strategies, and oversee CRO biometrics deliverables, ensuring high-quality, timely, and scientifically rigorous execution of clinical trials.

Key Result Areas (major Duties, Accountabilities And Responsibilities)

• Collaborate with cross-functional teams, including Clinical Development, Regulatory, and Clinical Operations, to support clinical study design, protocol development, clinical study reports (CSR), and regulatory submission documents.
• Review and support the development of Tables, Listings, Figures (TLFs) and ADaM specifications.
• Conduct literature research and review statistical methodologies for clinical data analysis.
• Represent the biostatistics function and proactively collaborate with internal and external cross-functional teams to ensure timely statistical deliverables.
• Develop TLF shells and ADaM specifications for ad hoc and post-hoc analyses.
• Communicate complex statistical concepts effectively in both written and verbal formats to diverse audiences.
• Oversee CRO statistical activities and manage contractors and vendors efficiently.
• Contribute to the development of Biostatistics SOPs and standards.
• Conduct clinical trial simulations and quantitative methods to inform study design and support data-driven decision-making

Qualifications & Skills

• Ph.D in Biostatistics, Statistics, or a related field required.
• At least 3 years of biostatistics experience in analyzing clinical trial data.
• Proficient in a broad range of statistical methodologies across different phases of drug development, including efficacy, safety, PRO endpoints, and innovative study designs.
• Experience in natural history cohort analysis is strongly preferred.
• Hands-on experience with SAS and R programming in clinical trials.
• Strong ability to manage multiple responsibilities simultaneously while maintaining high-quality standards and meeting deadlines under pressure.

US Salary Range

$188,000—$228,000 USD

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].

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