Senior Biostatistics ManagerVirtualVocations • Signal Hill, California, United States
Senior Biostatistics Manager
VirtualVocations • Signal Hill, California, United States
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A company is looking for a Senior Manager Biostatistics.
Key Responsibilities
Lead study-level tasks to ensure statistical integrity and contribute strategically to projects
Collaborate with biometrics and cross-functional teams to meet product deliverables and timelines
Conduct independent analyses and propose novel statistical methodologies to enhance study results
Required Qualifications
PhD in Statistics or Biostatistics with a minimum of 3 years of post-graduate experience in clinical trials; 6 years for Master's degree
Experience with NDA / BLA / MAA activities and regulatory interactions preferred
Proficient in study-level work, including authoring SAP and TFL specifications
Familiarity with ICH guidelines and FDA / EMA regulatory guidance
Knowledge of SAS and R; familiarity with CDISC standards such as SDTM and ADaM is preferred
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Senior Manager • Signal Hill, California, United States
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