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