Director will be primarily responsible for business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead; support virology drug development by collaborating on development plans, regulatory interactions, and commercial evaluation of a virology compound.
As a Director of Biostatistics, you will:
- Provide statistical leadership to virology clinical trials: develop trial design options and decision support.
- Serve as statistical lead for a virology molecule/indication in Health Authority interactions; maintain accountability thread to TA head.
- Collaborate cross-functionally (Statistical Programming, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory, Project Management) to meet analysis/reporting deliverables and timelines.
- Apply regulatory statistical principles to meet regulatory, scientific, and business objectives.
- Collaborate with investigators and experts to present and publish trial results and statistical analyses.
- Negotiate project timelines; plan long-term staffing; provide career development; participate in strategic risk assessment.
- Oversee and contribute to technical/operational statistical activities across multiple development programs.
- Provide departmental leadership and directly supervise personnel.
Requirements:
- PhD with 8+ years industry experience, OR MS with 10+ years, OR BS with 14+ years.
- Excellent verbal/written communication and interpersonal skills.
Preferred:
- Biomedical statistical analysis experience (SAS and R preferred).
- Drug development experience (phase 1β3 design/analysis; active participation in NDA/BLA filing; label negotiation).
Application (US): Apply via the Internal Career Opportunities portal in Workday (current employees/contractors).