Senior Director, Biostatistics

Role Summary

Senior Director, Biostatistics at Nuvation Bio. Lead strategic and operational statistical activities across multiple clinical development programs, with expertise in trial design, regulatory strategy, and cross-functional leadership. Manage a team of biostatisticians and collaborate with internal and external stakeholders to support regulatory submissions and data interpretation.

Responsibilities

• Define and execute statistical strategies for early to late-phase clinical trials.
• Lead biostatistics input for Clinical Development Plans, regulatory interactions, and submission packages.
• Represent Biostatistics in cross-functional leadership forums and project teams.
• Oversee study design, protocol development, SAP creation, and endpoint selection.
• Guide statistical analysis, interpretation, and reporting of clinical trial data.
• Ensure quality and compliance with ICH, FDA, and GCP guidelines.
• Manage and mentor a team of biostatisticians, fostering technical growth and leadership development.
• Lead vendor selection and oversight for outsourced statistical services.
• Prepare for and participate in regulatory meetings (e.g., EoP2, Advisory Committees).
• Provide statistical responses to regulatory queries and support submission documentation.
• Drive innovation in statistical methodologies and analytics tools (e.g., RShiny apps, innovative trial design).
• Collaborate with Programming, Data Management, Clinical Operations, Clinical Research, and Medical Affairs.

Qualifications

• PhD in Biostatistics, Statistics, or related field (Master‚Äôs with extensive experience may be considered).
• Minimum 10 years of experience in clinical trial statistics within the pharmaceutical or biotech industry.
• Proven leadership in strategic planning, regulatory submissions, and cross-functional collaboration.
• Expertise in SAS, R, CDISC standards (SDTM, ADaM), and statistical software (e.g., EAST).
• Strong communication and presentation skills with ability to influence across functions.
• Experience managing teams and mentoring junior staff.

Skills

• Strategic thinking and leadership
• Statistical methodology and data analysis
• Regulatory submission support
• Cross-functional collaboration
• Communication and stakeholder influence

Education

• PhD in Biostatistics, Statistics, or a related field (or Master‚Äôs with extensive relevant experience)