The Principal Bio-statistician is responsible for providing expert technical guidance to Bio statisticians and other staff on project teams.
The Principal Bio statistician oversees the entire design, development and evaluation process of the technical / statistical infrastructure for the conduct and evaluation of all clinical trials or for the analysis of complex research studies for which novel approaches are required, from inception to completion, and is recognized as one of the organization’s elite technical professionals.
Key Responsibilities :
Ensures compliance with and participates in development of Vertex SOPs and ICH GCP regulations Participates as a highly valued member of core teams for Phase II and III stages, clinical sub-teams, and core teams
Makes technical presentations, both internally and externally, and is recognized as an authority on a wide range of topics relevant to their area of technical expertise
Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to the project team
Acts as liaison on behalf of department with internal personnel and outside customer representatives at various levels concerning processes or scheduling of specific phases of projects or contracts In the role as project leader, conducts briefings and participates in technical meetings for internal and external representatives (e. g.FDA, EMEA, etc. )
Contributes significantly to the design of functional area goals and development
May supervise other Bio statistics staff
Possesses an advanced understanding of modern drug discovery and development processes.
Demonstrates advanced and inspiring intellectual and technical leadership
Directs own technical leadership and project teams to more meaningful and / or productive ends
Demonstrated highly advanced expertise in developing and incorporating novel methodologies into current processes and protocols
Proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives
Minimum Qualifications :
M. S.in Biostatistics and significant relevant work experience
Preferred Qualifications :
Ph. D.in Bio statistics and relevant work experience.
Vertex is a global biotechnology company that invests in scientific innovation.