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Contract Biostatistician

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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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