Medical Device Biostatistician
CyberScientific (Santa Barbara, California)

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Biostatistician jobs in Santa Barbara, CA Medical Device Biostatistician

This position is open as of 5/12/2008.

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Click Here to Apply Now! Job Details Medical Device Biostatistician Specifications Location     Santa Barbara, CA; Los Angeles, CA Salary     $80,000 - $100,000 Education     Bachelor of Science Category     Pharmaceutical Experience Required     At least 2 Years Short Description     Medical Device Biostatistician Required Skills     Biostatistician, Medical Device Pharmaceutical, SAS, Clinical Trial Design, Statistics Recruiter     David Wright Date Updated     5/12/2008 Job Description Skills Required

Biostatistician, Medical Device Pharmaceutical, SAS, Clinical Trial Design, Statistics

Job Description

Medical Device Biostatistician

We are one of the leading medical device companies and continue to launch important line extensions to our existing products that add value to doctors and patients. In addition, the company has made a number of strategic acquisitions and established key partnerships to expand its product portfolio.

Responsibilities:
* Involved in the development of new medical devices and biological products from inception through submission and post-market support worldwide.
* Provide expert level support for preclinical and clinical study design, case report form design, statistical analysis, and interpretation of study data.
* Provide statistical input to address regulatory questions.
* Develop and execute statistical analyses for studies and coordinates biostatistics support with internal and external functions such as CRO's.
* With the clinical, regulatory, and R&D teams, prepare detailed written statistical analysis plans including tables and listing shells and data summaries suitable for inclusion in regulatory submissions.
* Prepare detailed specifications and communicate to programmers for generation of analysis datasets (safety and efficacy analysis).
* Facilitate data review activities with project teams.
* Collaborate with and provide statistical support for clinical investigators and internal staff in the preparation of manuscripts and abstracts.

Requirements:
* PhD in biostatistics, statistics, or related field or MS in statistics
* 3+ years of work experience as a biostatistician in medical device, biopharmaceutical or CRO setting.
* Excellent verbal and written communication skills with demonstrated competency in scientific writing. * Superlative interpersonal and organizational skills with specific experience in working on multiple and complex projects across multifunctional teams.
* Work experience in an FDA regulated industry including working knowledge of GLP and GCP. * Experience in clinical trial design and analysis with experience with patient reported outcomes and quality of life measure.
* Thorough knowledge of statistics including linear models, multivariate analysis, Bayesian design, and non-parametric analysis.
* Demonstrated ability to effectively work across functions and with internal and external professionals at al levels.
* Must be proficient with computers and software such as Word, Excel, and PowerPoint.
* SAS knowledge a must.
* Must be able to effectively communicate with non-staticians.

Location: Santa Barbara, California; Los Angeles, California Want to interview today? Click Here to Do a Quick 2-Minute Online Interview!

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David.Wright@CyberScientific.com
**Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-CA-Biostat -- in the email subject line for your application to be considered.***

David Wright - Senior Recruiter - CyberScientific