Director, Biostatistics - Virology - Foster City, CA or Parsippany, NJ

Key Responsibilities

• Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.
• Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head.
• Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives.
• Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.
• Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.
• Expected to oversee and contribute to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources.
• Provides overall leadership for a departmental strategic initiative with experience directly supervising personnel.

Basic Qualifications

• PhD with 8+ years of industry experience OR
• Masters degree with 10+ years of industry experience OR
• Bachelors degree with 12+ years of industry experience

Preferred Qualifications

• Extensive hands-on experience in drug development including trial design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation
• Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)
• Effective verbal and written communication skills with the ability to convey complex concepts in clear, concise, and accessible language
• Strong collaboration and interpersonal skills with demonstrated success in fostering effective relationships and working seamlessly within diverse cross-functional team
• Adept at analyzing challenges from a holistic, cross-functional viewpoint to align with broader organizational or project goals
• Anticipates obstacles and understands stakeholder needs to proactively develop and implement practical and effective solutions
• Demonstrated ability to assemble and lead high-performing teams, providing clear direction and fostering a shared vision for success
• Proactive and creative innovator who applies strategic thinking and statistical expertise to develop practical solutions, improve trial design and execution, and support program- and portfolio-level data-driven decision making