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Title:Senior Biostatistician
Salary:Open
Experience:2-7
Location:CA - South San Francisco

Description:
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy and marketability of compounds.  Projects, prepares the statistical component of protocols which meet project objectives, guidelines and clinical trial methodology standards.

Responsibilities:
  • Provides written and verbal recommendations on quantitative/statistical and data management issues.
  • Works with the project team members and manages CRO to generate clinical protocol, CRFs, CRF edit specifications, database, analysis plan and final study report for clinical development projects.
  • If appropriate, interacts with and manages counterparts at CROs
  • Interprets the project implications of regulatory guidelines.
  • Interacts with FDA or other regulatory agencies as appropriate in statistical and data management aspects of study design, database, and data analysis.      

Requirements:
  • BS/BA degree in related discipline and seven (7) years of related experience;
    • or, MS/MA degree in related discipline and five (5) years of related experience;
    • or, PhD in related discipline and two (2) years of related experience, or;
    • Equivalent combination of education and experience.
  • May require certification in assigned area
  • Experience in Biotech/Pharmaceutical industry preferred.
  • Demonstrated experience with statistical applications and clinical data management procedures in the conduct of clinical trials

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