Principal Biostatistician

Position Summary:

The Principal Biostatistician is responsible for overseeing biostatisticians within the Data
Management and Statistics Department staff to ensure accurate and timely completion of all
statistical activities. In addition, the Principal Biostatistician provides expertise across several
therapeutic areas in all phases of clinical trials and combines statistical expertise, technical
knowledge on data processing and the ability to handle complex scientific/medical aspects of the
study to ensure all activities are carried out in compliance with the clinical study’s requirements,
the Company’s processes as well as the Sponsor’s processes and regulatory requirements, as
applicable.

Main

Duties & Responsibilities:

Ensures all biostatisticians are adequately technically qualified, as well as trained on
Company processes related to activities assigned Is responsible, for coordinating the biostatisticians team to ensure the accurate and timely completion of all statistical activities for assigned projects.
Escalates and acts on risks in relation to the milestones of pending statistical activities
Acts as the study assigned biostatistician for complex studies, providing statistical
oversight and attending relevant project meetings
Monitors project budgets and tasks, and escalates issues to the Director, Biometrics, as
appropriate
Reviews Statistical Analysis Plans (including mock TFL shells), as appropriate
Works closely with the Clinical Science Department and other Company Departments, to
provide statistical expertise and lead the statistical analysis to ensure that the study needs
are fulfilled
Provides input to deliverables prepared by less experienced biostatisticians in the
department, as needed
Reviews and approves scientific abstracts, posters and manuscripts, prepared by less
experienced biostatisticians in the department
In collaboration with the Senior Biostatistician, provides statistical expertise on the
projection of milestones, drug expectations and other statistics-related tasks
Complies with the Company's Quality and Information Security Management Systems
and applicable national and international legislation, including legislation for data
protection

Professional Experience Requirements:

−

Required:

6 years of biostatistics experience in a CRO, a pharmaceutical or equivalent
organization
− Desirable:
o Strong experience in statistical computing (R/SAS or similar statistical
programming language)
o Participation in studies with FDA submissions (CDISC standards) and previous
working experience with phase III studies with multiple interim analyses will be
considered as a strong plus