• Lead and coordinate statistical related activities to support clinical studies including design, execution, analysis, interpretation, and reporting of clinical trials • 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 • Create or validate SAS programs for data management activities, compliant analysis datasets, and statistical analysis of 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.