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Company: Well established Biopharmaceutical Company located in the San Diego area
Title: ASSOCIATE DIRECTOR, BIOMETRICS
GENERAL SUMMARY:
To plan, direct and implement all aspects of biostatistical analysis and support to the development of new products, domestic and international regulatory submissions in a given therapeutic area.
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PRINCIPAL DUTIES/RESPONSIBILITIES:- Direct biostatisticians, programmers and data management staff which provide leadership and support to multiple projects within a therapeutic area under the leadership of project leader.
- Closely interact with the project leaders to coordinate and deliver biostatistical support, consultation, and direction for this discipline in a therapeutic area and communicate results with department head.
- Work with project clinicians to develop study design and statistical analysis plan for phase I-IV clinical protocols.
- Work with project data associates and programmer analysts to ensure the validity and accuracy of the summary tables, graphs and data listings for the integrated statistical/clinical report.
- Work with project clinicians and medical writers to ensure the completeness and accuracy in the content of the integrated statistical/clinical report.
- Work with department head to develop and implement biostatistical support systems focused on meeting or exceeding project requirements.
- Represent the company to interact with the FDA, corporate partners and CROs on the biostatistical aspect of the product development for a given therapeutic area.
- Supervise biostatisticians and statistical analysts of various levels in a given therapeutic area.
- Provide statistical consultation to scientists in the areas outside medical affairs division.
- Attends internal and external meetings and/or seminars.
Compensation: $90,000 Plus
Relocation: Yes
Sincerely,
Steve Sutter
Senior Recruiter
Allen-Jeffers & Associates
stsutter[at]aol.com
805-529-4161
http://www.allen-jeffersassociates.com
[Please reference Bioinformatics.Org when replying to this announcement.]
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