Director, Biostatistics

Job Description

The Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead. He/she will support Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in one or more indications.

Requirements

• 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.
• Oversees and contributes 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.

  Qualifications

  • PhD with 8+ years of industry experience OR Masters degree with 10+ years of experience or Bachelors degree with 14+ years of experience.
  • Excellent verbal and written communication skills and interpersonal skills.
  • Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred).
  • Extensive hands-on experience in drug development including design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation.
  • 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.