http://jobs.metafilter.com/tags/FDA Posts tagged with 'FDA' at MetaFilter Jobs. Fri, 16 May 2008 06:34:56 -0800 Fri, 16 May 2008 06:34:56 -0800 en-us http://blogs.law.harvard.edu/tech/rss 60 http://jobs.metafilter.com/mefi/444 We have an exciting opportunity for an experienced biostatistics professional to work from home carrying out advanced multivariate statistical analyses for a cutting-edge molecular diagnostics company. You will be working with clinical biomarker data, developing predictive methods which will help to advance health care research. You should have advanced experience with multivariate statistical methods, including supervised and unsupervised algorithms such as support vector machines and neural networks, and robust cross-validation models. Some experience with statistics for clinical trials (power & bias calculations) would be valuable. The ideal candidate will have 10-15 years of experience in an FDA/Health Canada or health diagnostics technology environment. Advanced education (MSc/PhD) in statistics is preferred but BSc. candidates with substantial industry experience will be considered. This is a Canadian company but because it is work-from-home, US candidates are also invited to apply. We welcome applications from self-employed and incorporated consultants. tag:jobs.metafilter.com,2008:site.444 Fri, 16 May 2008 06:34:56 -0800 biomarkers biostatistics clinical diagnostics FDA sevenyearlurk http://jobs.metafilter.com/mefi/320 My firm has been engaged to expand the capacity of the Regulatory Affairs department for an innovative biotechnology firm on Canada's beautiful west coast. We are looking for experienced, skilled RA professionals to manage the regulatory approvals process for Canada and the United States as the company moves several drug candidates through the final stages of clinical development. There are opportunities at the Associate Director level as well as less senior positions for submissions specialists and CMC regulatory associates. Candidates should have significant experience with regulatory submissions to the FDA and TPD (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence). Experience with electronic submissions will be especially valuable. Detailed job descriptions are available upon request. tag:jobs.metafilter.com,2007:site.320 Thu, 18 Oct 2007 06:26:34 -0800 biotechnology FDA pharmaceutical regulatoryaffairs TPD sevenyearlurk