Executive Director, Biostatistics

uniQure is dedicated to bring 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.

The Executive Director, Biostatistics, is responsible for providing strategic statistical input related to multiple clinical programs and the whole portfolio decisions. They will partner closely with cross functional teams to provide expert input on development plans, regulatory interactions, and study design, reporting and interpretation. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. They will define the strategy for providing the appropriate statistical support through a combination of internal staff and external vendors. This individual will ensure systems, capabilities and resources are in place that efficiently supports our development programs.

Key result areas (major duties, accountabilities and responsibilities)

• Serve as functional leader to support multiple clinical stage programs. Ensure that development teams obtain appropriate strategic input and technical expertise on statistical methodologies for clinical studies
• Provide strategic guidance to ensure high quality preparation of Regulatory Authority documents i.e. clinical study reports, submissions, clinical protocols and safety reports
• Ensure the accurate communication of clinical trial data internally and externally; ensure that the interpretation of data from clinical studies is accurate, scientifically sound and credible
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team
• Develop and maintain statistical/programming policies, guidelines, and procedures (SOPs, training manuals, etc.)

Qualifications & Skills

• PhD in statistics or biostatistics required with minimum of 13 years of experience in the pharmaceutical and/or biotechnology industry
• Management experience with proven capability as a successful leader in a strategic multifunctional environment
• Strong business acumen and critical thinking skills
• Must possess a comprehensive and detailed understanding of statistical experimental designs and analyses, clinical trial requirements and statistical technical requirements such as SAS, SDTM and CDISC
• Understanding of regulatory guidelines that affect statistical deliverables including ICH, FDA and GCP regulations
• Experience in gene therapy and rare diseases preferred
• Strong interpersonal and effective communication (oral and written) skills
• Ability to efficiently manage CROs