Staff Scientist (Biostatistician) 8/26/2016
JOB DESCRIPTIONAPPLY Job Description
At the Digital Biology Center (a division of Bio-Rad) we use nanoliter-sized droplets as reaction vessels to power a super-precise digital nucleic acid measurement method (droplet digital PCR). Now that we ve solidified our market lead in digital PCR, we re expanding into diagnostic applications for our core technology. We think a lot of interesting molecular biology can be done with thousands of nanoliter-sized reactors.
We need someone to help design, analyze and prepare our data for FDA submissions for new ddPCR assays. This includes developing quality and pass/fail metrics for feasibility and final software, filtering and reformatting datasets for secondary analysis, and judging appropriateness of study designs (for power and validity). We will need you to determine LOD, LOQ, and LOB for our (very sensitive) assays according to CLSI standards.
We re looking for a statistician with superb communication skills, substantial regulatory experience and experience in molecular biology, bioinformatics, and computer science. You should be jazzed about working on a cool technology and being deeply embedded in a team of molecular biologists, computational biologists, programmers, and engineers.
You ll be part of the Computational Biology Team working with the folks who design new types of assays, develop the metrics to evaluate the system, write internal and external software tools to enable users to design and validate their own assays, and make sense of NGS data to drive new product development.
* You're a solid statistician, with at least five years' experience working on significant regulatory projects. You have experience with standard statistical techniques, including hypothesis testing, regression analysis, linear and non-linear models, data aggregation and visualization. You know and comfortably use some of (R, S, SAS, jmp, python, etc.).
* You have taken at least two diagnostic products through FDA submission. You are familiar with CE/IVD regulations as well.
* You know how to set up CLSI/analytical studies, clinical trial design and analysis because you ve done it before
* You don't expect to get all the requirements in advance. You are comfortable engaging in a back-and-forth with scientists, marketing, and regulatory personnel to figure out what we really need to provide. You can do this because you re a superb communicator.
* You enjoy sharing your expertise. You make everyone around you better. You like working as part of a team.
* Familiarity with ddPCR and/or NGS a plus.
* You have at least an MS in a relevant field, PhD preferred.
Some publications about our technology:
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
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