Director, Biostatistics
Core
Provides leadership and guidance for large and/or complex late phase clinical development programs, designing innovative clinical trials and leading statistical activities for regulatory submissions.
Role type
Director, Biostatistics (Senior Leadership)
Builds
Clinical study reports, regulatory submissions, scientific manuscripts, and statistical analysis plans for late-phase clinical trials.
Domain
Pharmaceutical/Biotechnology, Clinical Development, Biostatistics
Deliverable
client delivery | production ML models (statistical models)
Required skills
Clinical trial design, statistical analysis plan development, regulatory submission support, strategic planning, team leadership, data interpretation, manuscript authoring, timeline management
Preferred skills
Pharmaceutical statistics experience, communication skills
Technologies
ADaM, eCRF
Responsibilities
Contribute to strategic thinking and Clinical Development Plan development; Lead large and/or complex late phase clinical development program(s); Author statistical sections of clinical trial protocols and statistical analysis plans; Review and approve stratification/randomization schema; Collaborate with Data Management and Clinical Operations on design of eCRFs; Provide statistical guidance on conduct of ongoing trials; Collaborate with Statistical Programmers on summary and analysis of trial data; Interpret and communicate results of statistical analysis for regulatory submissions and manuscripts; Contribute to clinical study reports and regulatory documents; Lead biostatistics support for worldwide regulatory submissions; Represent company in meetings with regulators and stakeholders; Consult with cross-functional colleagues on statistical questions; Manage timelines across clinical development programs.
