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Celcuity · 1 hour ago

Director, Biostatistics

United States

Full-time

Remote

Director/Executive

$230K/yr - $260K/yr

10+ years exp

Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. The Director of Biostatistics will lead statistical activities for clinical studies, ensuring quality assurance and control of analyses, while collaborating with cross-functional teams and maintaining project materials.

BiotechnologyHealth CareHealth DiagnosticsTherapeutics

Responsibilities

Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence

Support for the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represents the Biostatistics function for cross-functional and intra-departmental teams or working groups

Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed

Create or validate SAS programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data

Prepare the statistical section of clinical trial reports and presentations of the results to the team

Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development

Writing statistical reports and memos with minimal guidance

Validating complex datasets or summary tables

Prepares and documents facts to enable management to write and support trial reports and publications

Other duties as assigned

Qualification

BiostatisticsClinical trials experienceSASROncology clinical trialsPlanningOrganizationContinuous improvement mindsetCommunicationProblem-solvingFlexibility