Sr. Director, Biostatistician - Chandler, AZ | Biospace
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Sr. Director, Biostatistician

Insys Therapeutics

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Location:
Chandler, AZ
Posted Date:
6/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
MBA
Areas of Expertise Desired:
Biostatistics, Biotechnology, Clinical Trial, Regulatory, Regulatory Affairs, SAS, Statistics,

Job Description

The Senior Director, Biostatistician supports (with review) trial planning and analysis activities in support of clinical trials, regulatory approval, and marketing efforts. The Biostatistician assists in preparing development programs for new drug indications. This individual provides primary statistical input for clinical study design. S/he provides analysis planning for clinical studies. S/he provides statistical input to clinical study reports. This individual provides statistical support to other disciplines related to clinical statistics.

The Senior Director, Biostatistician will interface with Biostatistics staff, clinical teams, and associated working groups. This individual will be involved in communication with SAS programming, clinical data management, clinical trials management, regulatory affairs, clinical communications, clinical pharmacology, medical writing, and quality management.

ESSENTIAL FUNCTIONS:
•   Plan and monitor statistical activities for a project
•   Communicate with the sponsor and other participants of the project
•   Help prepare the statistical design of clinical trials
•   Prepare Statistical Analysis Plans
•   Program analysis datasets, pooled datasets, tables, listings, graphs and statistical analyses for clinical trials
•   Conduct statistical analyses and quality control
•   Conduct Data Monitoring Committee analyses
•   Assist the writing of the clinical study report
•   Train and coach other biostatisticians
•   Perform other duties related to the work described above

Requirements

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•   MS or PhD in biostatistics, statistics or mathematics.
•   Minimum of 5 years biotech/pharmaceutical/CRO experience
•   Experience with SAS programming is required (knowledge of R would be an asset)
•   Experience with Data Monitoring Committees is required
•   Understanding of clinical trial practices, procedures and methodologies
•   Strong computer and analytical skills
•   Good written and verbal communication skills
•   Fluent in English
•   Ability to set priorities and respect tight deadlines
•   Problem solving skills, team player