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The Biostatistician is responsible for quality and timely statistical support to the assigned tasks under the supervision of the biostatistics Director. Essential Duties/ Responsibilities  Serves as a study statistician for Phase 1 or 2 studies on the study teams Represents ...

Job Description

The Biostatistician is responsible for quality and timely statistical support to the assigned tasks under the supervision of the biostatistics Director. 

Essential Duties/ Responsibilities 

  • Serves as a study statistician for Phase 1 or 2 studies on the study teams
  • Represents Biostatistics in study team meetings
  • Develops Statistical Analysis Plans, creates mock-ups for tables, listings, and figures; ensures cross-functional review of those documents is conducted and comments are adjudicated and incorporated as appropriate
  • Collaborates with statistical programming to ensure appropriate datasets development and outputs generation
  • Reviews tables, listings, and figures produced by statistical programming according to the specifications to ensure accuracy and validity of results
  • Provides input on study design, review protocols and author statistical section of a protocol
  • Reviews clinical study reports to ensure accuracy and consistency in data presentation, data interpretation statistically sound
  • Provides statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts), reviews publications to ensure accuracy and consistency in data presentation, and data interpretation statistically sound
  • Develop statistical programs as necessary to perform exploratory analyses 
  • Provide statistical consultation on PK/PD and biomarkers analyses in clinical and pre-clinical studies 
Requirements
  • Experience applying statistical methods to drug development and clinical trials
  • Understanding of regulatory guidelines in a pharmaceutical research setting
  • Excellent communication skills and ability to consistently meet company urgent deliverables
  • Strong implementation skills
Education/Training
  • PhD or MS in Statistics/Biostatistics with prior experience in biotech/pharma industry as a statistician
  • Hematology oncology drug development experience is highly preferred
  • Proficient in SAS and/or R programming
  • Experience with PK/PD analysis is desirable