Principal Biostatistician (Medical Affairs Required)
Updated: October 1, 2024
Location: Spain-Europe - ESP-Home-Based (Madrid)
Job ID:24005267
Remote Principal Biostatistician - Must be in NA or EMEA (Prior Medical Affairs experience is required)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job ResponsibilitiesServes as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions or otherwise trains new hires and enhances the skills of existing personnel.Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians in the department.Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.Implements company objectives and creates alternative solutions to address business and operational challenges.As biostatistics representative on project teams, interfaces with other departmental project team representatives.Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.May lead complex or multiple projects (e.g., submissions, integrated analyses), and attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study-related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met.
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