Associate Director, Biostatistics - Virology

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

10+ Years with BS OR 8+ Years with MS OR 2+ Years with PhD/PharmD OR 0+ Years with MD

Preferred Qualifications

• 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

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.