Biostatistics Sr Mgr - South San Francisco, CA | Biospace
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Biostatistics Sr Mgr

Amgen

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Location:
South San Francisco, CA
Posted Date:
12/10/2016
Position Type:
Full time
Job Code:
R-31053
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Serves as a resource and may act as a statistical expert for protocol development by identifying issues and innovative solutions related to design and statistical analysis May represent Biostatistics in Core Project teams on operational and strategic decisions related to assigned projects Train in all of the applicable Standard Operating Procedures (SOPs) and addresses all other activities involved with developing and enhancing the Biostatistics dept. May serve as a project lead responsible for resource, milestones, and priorities for Biostatistics deliverables Responsible for coordinating with internal and external team members. May represent Biostatistics in meetings with regulatory agencies and prepares oral/written responses to agency questions

Requirements

Basic Qualifications:

Doctorate degree and 2 years of Clinical experience

OR

Master's degree and 6 years of Clinical experience

OR

Bachelor's degree and 8 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma / GED and 12 years of Clinical experience

Preferred Qualifications:

Solid understanding of theoretical and applied statistics, especially in the areas of generalized linear model, survival analysis and Bayesian statistics Solid understanding of regulatory guidelines (FDA, EMA) in clinical study design/analysis/reporting 4+ years as a statistician in a pharmaceutical or biotech industry with clinical trial/regulatory interaction (including NDA filing) experience, especially in oncology area Fluency in R and SAS Good written and verbal communication Solid analytical/problem solving skills Direct report management experience and project/process management experience preferred