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Principal Biostatistician:

Roles and Responsibilities

• Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.
• Can develop SAPs and iSAPs text and shells with no supervision.
• Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction.
• Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments.
• High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.
• Has the ability to apply drug development knowledge during production of complex statistical analyses.
• Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study.
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers.
• Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management.