Senior Biostatistics Manager

hace 4 semanas


Zaragoza, Zaragoza, España Syneos Health A tiempo completo

Job Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization. We are seeking a highly skilled Senior Biostatistics Manager to join our team.

Key Responsibilities

  • Provide statistical leadership and mentorship to biostatisticians on job skills and oversee training plans or materials for Biostatistics associates.
  • Conduct training sessions or otherwise train new hires and enhance the skills of existing personnel.
  • Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
  • Provide independent review of project work produced by other biostatisticians in the department.
  • Support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
  • Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
  • Collaborate 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.
  • Create or review programming specifications for analysis datasets, tables, listings, and figures.
  • Review 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.
  • Implement company objectives, and create alternative solutions to address business and operational challenges.
  • As biostatistics representative on project teams, interface with other departmental project team representatives.
  • Conduct and participate 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.
  • Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study-related activities with biostatistics management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate to biostatistics management any difficulties with meeting these timelines.
  • Monitor progress on study activities against agreed-upon milestones and ensure the study timelines for project deliverables are met.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.



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