Senior Biostatistician

This is a remote position.

Responsibilities:

• Train and mentor statisticians on non-project-linked tasks.
  
• Offer consultation on experimental design, statistical strategies, and approaches for the purpose of examining safety and efficiency of drug products.
  
• The ideal candidate will prepare for and attend internal and third-party study audits pertinent to statistics.
  
• Evaluate and QC statistical deliverables such as tables, listing, figures, etc.
  
• Mediate with DM on statistical questions connected to data concerns, which involves arranging data transfers from DM to statistics.
  
• Guide all biostatistics actions connected to clinical trials as an accountable project statistician.
  
• You will develop and document analysis database structures such as SAS analysis dataset structures.
  
• Discuss line for project teams, which involves statisticians and SAS Programmers.
  
• Contribute to the development of regulations, processes and any other quality systems documents relevant to actions of the biostatistics division.
  
• Other duties may be assigned to this role.
  

Requirements

Key Skills and Requirements:

• Educated to an advanced degree level in a statistics or similar field.
  
• Capable of implementing a variety of evolved statistical practices in assistance of clinical research studies and to analyze, comprehend, and draw conclusions from multifaceted statistical information.
  
• Able to consult with clinical investigators, comprehend research needs and establish statistical analysis methods.
  
• Demonstrable experience within relevant industry on clinical research, biostatistics and SAS programming.
  
• Know-how and comprehension of the statistical principles, ideas, strategies and standards used within clinical research.
  
• Capable of representing biostatistics in bid defenses.
  
• Know-how of pertinent guidelines and regulations, such as FDA, EMA, ICH, etc.
  
• Presentation and communication skills both verbally and in writing.
  
• Expertise on SAS software with computer literacy.
  
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