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| Employer Name: BiotechCrossing |
SpiderID: 2298682 |
| Location: Memphis, Tennessee |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5388830 |
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Job Description:
SUMMARY: Responsible for the coordination and conduct of statistical activities, including pre-clinical research, pre-market, post-approval, marketing, and outcome studies. Position Responsibilities ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Comply with appropriate regulatory requirements and follow regulatory guidance, use sound scientific/statistical principles and judgment, and serve as a resource of consultation for clinical research and development. Develop and refine objectives for pre-clinical, clinical, and post-approval studies. Consult with management and appropriate personnel to develop study designs. Consult with management and appropriate personnel to determine study assumptions for calculating sample sizes and determine the sample sizes, as well as help assess the risk factors to study success (regulatory approval of investigational products).. Develop and document analysis plans by employing both Bayesian and frequentist methodologies, data forms, and procedures for clinical studies.QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: Master's degree in statistics or biostatistics is required. Prior experience with FDA and other regulatory submissions is essential. OTHER SKILLS and ABILITIES: Proficiency in SAS programming. Experience with personal computer software (MS Office). In-depth knowledge of clinical research methodology, FDA and ICH regulations, and submission process. Some overnight travel required. Desired/Preferred Qualifications An M.S. with more than seven years, or a Ph.D. with more than four years, of pharmaceutical and/or medical device industry or clinical research experience is preferred. Training in Bayesian statistics is highly preferred, although not required. Prior management experience in biostatistics is plus. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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