Roles and Responsibilities Lead complex projects, programs and submissions, manage client meetings, CRMs, collaborate 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 as...
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