Senior Biostatistician

  • Contract
  • Remote

SimulStat

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Responsibilities:
•    Provide statistical expertise in the design, analysis, and reporting of clinical studies. 
•    Partner with cross-functional teams to define analysis scope and timelines. 
•    Develop statistical analysis plans and detailed analysis specifications. 
•    Conduct and perform quality control on statistical analyses, including statistical modeling as needed. 
•    Collaborate with statistical programming teams to ensure analyses are conducted per plan and specifications. 
•    Work with data management and clinical operations to support robust data collection and database development. 
•    Contribute to the development and review of scientific publications, ensuring data consistency and accuracy. 
•    Author and review statistical sections of regulatory submissions and responses, ensuring clarity and accuracy in data presentation. 
•    Represent the biostatistics function on study teams and contribute to cross-functional decision-making. 

Required Skills, Experience, and Education:
•    Advanced degree (Ph.D. or M.S.) in statistics, biostatistics, or a related field, with relevant industry experience. 
•    Experience supporting late-stage onocology clinical development is required. 
•    Experience with regulatory submissions and interactions with regulatory agencies is preferred. 
•    Proficiency in statistical programming tools (e.g., SAS and/or R). 
 

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