Associate Director, Biostatistics — Clinical Strategy

UniQure NV; 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

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.