Position Title: |
Mgr, Biostatistics I |
Position Number: |
50061126-002 |
Department: |
Research & Development |
Location: |
Irvine, CA or Bridgewater, NJ |
Description
The position provides the statistical and analytical leadership
to the drug development projects by exploring and defining the
relationship between pharmacokinetic and pharmacodynamic data to
optimize the dose and regimen selection through analysis of exposure
and response. The incumbent will provide expedient and effective
statistical support by using or developing advanced quantitative
methodology and tools for the exploration, modeling, analysis,
presentation, and interpretation of PK and PK/PD data. The incumbent
will ensure compliance with appropriate global regulatory requirements
and interact with domestic and foreign regulatory agencies for Allergan
R and D projects.
Position Requirements
- Education or education/experience combination equivalent to a post
graduate degree in statistics or statistics related field. At least
four (4) years of pharmaceutical experience with a Ph.D. or Ph.D.
equivalent. At least six (6) years of pharmaceutical experience with a
masters degree or masters degree equivalent.
- At least 3 years of experience with PK/PD analyses by quantitative
modeling and simulation.
- Statistical leadership in early phase drug development with pre
clinical and phase I/II studies
- Statistical expertise with regard to clinical and pre clinical
studies in Methodology; analysis of variance, mixed linear models,
mixed non linear models, Bayesian analysis, trial simulation,
compartmental modeling, categorical data analysis, reliability,
multivariate analysis, robust estimation, nonparametric techniques.
- Statistical expertise with regard to clinical and pre clinical
studies in Analysis; individual, average, and population PK analyses,
bioequivalence, bioavailability
- Statistical expertise with regard to clinical and pre clinical
studies in Design; cross over, incomplete block, sample size and power
- Solid knowledge and experience in computing tools such as S Plus,
NONMEM, WinNonLin, SAS
- Solid knowledge in global regulatory guidance documents and
requirements
- Solid knowledge of at least one relevant therapeutic area of drug
development
- Knowledge in drug absorption, distribution, metabolism, and
excretion
- 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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