DESCRIPTION

The Director of Biostatistics directs the activities of managers and biostatisticians as well as CROs and consultants. This role is responsible for all statistical input to clinical development and assures compliance with regulations and timely completion of deliverables. The Director will be responsible for departmental resourcing and policies.

RESPONSIBILITIES

Essential Functions of the Position:
Directs activities of the biostatistics department.
Develop career paths for biostatisticians.
Ensures timely completion and delivery of work product.
Provides written monthly summary reports of departmental activities.
Works with Manager Clinical Data Reporting to coordinate programming and statistical activities and timelines.
Interacts with Data Management, Clinical, Regulatory and Project Management groups.
Develops and maintains departmental Standard Operating Procedures (SOPs) for biostatistical services.
Monitors consistency of implementation through audits conducted at least annually and documents findings in written annual summary report.
Ensures biostatistical support and review of regulatory documents such as Clinical study Reports, Integrated Summaries of Efficacy, etc.
Maintains expertise in regulations that apply to biostatistics in the pharmaceutical industries.
Ensures biostatisticians understand current regulations that affect their roles.


REQUIREMENTS:
Ph.D. in biostatistics, statistics, mathematics, or related field.
Minimum of 8 years experience in the pharmaceutical or biotechnology industries with at least 4 years management experience.
Strong interest in management and organization.
Excellent analytical, problem solving, and computer skills.
Flexible, well organized, excellent verbal and written communication skills, and interpersonal skills.
Works well under pressure, strong team player.
Ability to travel 10% of the time.

HOW TO APPLY

Please apply to http://www.careers[at]coruspharma.com OR cwhitney[at]coruspharma.com
(no 3rd party agencies please)