Associate Director, Biostatistics
Apply NowCompany: uniQure N.V.
Location: Lexington, MA 02421
Description:
Associate Director, Biostatistics
Location:
Lexington, MA
Education level:
Master or PhD
Job category:
Clinical Development
Target start date:
4/1/2025
Work Location:
Hybrid
Shift:
1st
uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
This role is responsible for supporting statistical activities in clinical trials, including contributing to trial design, developing statistical analysis plans, supporting regulatory documents, and reviewing and interpreting clinical trial data analyses.
Key result areas (major duties, accountabilities and responsibilities)
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Location:
Lexington, MA
Education level:
Master or PhD
Job category:
Clinical Development
Target start date:
4/1/2025
Work Location:
Hybrid
Shift:
1st
uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
This role is responsible for supporting statistical activities in clinical trials, including contributing to trial design, developing statistical analysis plans, supporting regulatory documents, and reviewing and interpreting clinical trial data analyses.
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.
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- Minimum MSc in Biostatistics, Statistics, or a related field required; Ph.D. strongly preferred.
- At least 5 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.
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