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Title:Manager, Biostatistics
Salary:Open
Experience:5-7
Location:CA - San Francisco

Description:
As the project statistician for assigned clinical programs, the position represents BDMP on project teams advising team members in drug development strategies.

Responsibilities:
  • Plans all aspects of data analysis for assigned projects
  • Has responsibility for the preparation and maintenance of the Analysis Plan (AP)
  • Ensures the quality controlled production of all tables, listings and graphs for the clinical document while adhering to the pre specified analyses and timelines.
  • Interacts with domestic and foreign regulatory agencies for projects.
  • The position may serve on company and/or departmental teams and make recommendations for departmental standards.

Requirements:
  • Education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field.
    • At least five (5) years of pharmaceutical experience with a Ph.D. or Ph.D. equivalent.
    • At least seven (7) years of pharmaceutical experience with a masters degree or masters degree equivalent.
  • Statistical expertise with regard to clinical studies Design; cross over, multiplicity, interim analyses, non inferiority, sample size and power.
  • Statistical expertise with regard to clinical studies Analysis; treatment by center interaction, multi center, missing value imputation, covariate, and subpopulations.
  • Statistical expertise with regard to clinical studies Methodology; analysis of variance and mixed linear models, survival analysis, categorical data analysis, reliability, multivariate analysis, robust estimation, nonparametric techniques, and group sequential analyses.
  • Solid knowledge in global regulatory guidance documents and requirements.
  • Flexible, well organized, excellent verbal and written communication skills and interpersonal skills.
  • Working knowledge of SAS.
  • Excellent oral and written communication skills.
  • Excellent interpersonal skills
  • Excellent analytical, problem solving, and computer skills.
  • Flexible and well organized with the initiative to take on unfamiliar tasks and work well under pressure.

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