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Senior Biostatistician

Seattle Genetics, Inc.

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Location: Bothell, WA Posted Date: 4/16/2013 Position Type: Full time Job Code: 1302LS-01 Required Education: High school or equivalent

Description

•   Perform sample size and power calculations
•   Review CRFs and edit checks
•   Develop SAP and create table, listing, and figure shells
•   Perform statistical analysis as defined in SAP
•   Able to code complex statistical analyses as needed; familiar with good coding practices
•   Lead clinical study with limited oversight
•   Interpret results and write sections of documents; present results
•   Support project or lead statisticians in preparing for interactions with regulatory agencies
•   Assist in regulatory submissions with limited oversight
•   Coordinate and supervise work performed by junior biostatisticians
•   Read and understand Medical/Clinical literature as required by duties
•   Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
•   Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process
•   Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
•   Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Requirements

•   At least 5 years in pharmaceutical/biotechnology clinical trials or related environment - Masters level in Statistics, Biostatistics, Epidemiology or related field
•   Good programming skills and knowledge of SAS, knowledge of R a plus
•   Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
•   Able to prioritize work and complete deliverables to timelines with some supervision
•   Excellent verbal and written communication skills
•   Detail and process oriented
•   Oncology experience preferred

Seattle Genetics is an Equal Opportunity Employer.
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