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About Gen-Probe:
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Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) used primarily to diagnose human diseases and screen donated human blood.
At Gen-Probe, our energized workforce functions as a team to make a significant impact towards our company's mission of revolutionizing healthcare.
Our state-of-the-art research and manufacturing facility is located among internationally respected educational institutions such as Scripps, Salk and UCSD in beautiful San Diego. If you want to work for a company that "is going places", then you want to work for Gen-Probe.
Click here to go to the Gen-Probe website.
For details about Gen-Probe, click here.
About the Opportunity/Requirements:
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Employer Job Code: G08/134/JF
“The Power to Look Deeper”
Gen-Probe, a global leader in research, development & manufacturing of nucleic acid diagnostics, offers opportunities in the advancement of healthcare. One of San Diego’s leading biotechs, we offer state-of-the-art facility with world-class benefits. We’re currently seeking team members who have “The Power to Look Deeper” in developing the best products, technologies and service.
“The Power to Shape Your Future”
Are you an experienced Biostatistician? Gen-Probe is working on diagnostics that save lives through early detection of current and future health threats. Would you like to contribute to this important work? If so, we want to hear from you!
RESPONSIBILITIES:
Manages resources, project priorities & timelines for clinical trials.
Participates in strategy development & contingency planning.
Designs, documents, tests & implements statistical methods with Clinical Affairs & other departments.
Works on Clinical Affairs project teams on CRF design.
Provides input on Data Management SOPs & provides input on Biostatistical SOPs and work instructions.
Develops statistical programs for data analysis & presentation; works with SAS programmers for appropriate data analysis.
Writes Statistical Analysis Plans (SAPs)
Develops table/listing/graph shells for statistical analyses and reports.
Writes the statistical and data analysis sections of regulatory submissions.
Acts as statistical consultant to solve statistical problems for other departments.
Interfaces with clinical investigators & scientists to determine protocol design.
Ensures integrity of data that support regulatory submissions.
Contributor to FDA (and other regulatory) interactions
RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
Knowledge of CRF and database development, including attribute assignment and logic checking.
Knowledge of statistical software packages - SAS and/or S-Plus.
Knowledge of statistical theory and methods for clinical trials.
Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
Knowledge of infectious disease, cancer, genomics and common public health issues.
Technical writing.
Ability to work with cross functional teams to develop strategies for study design and FDA interaction.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Requires a PhD in Statistics/Biostatistics or equivalent in engineering and a minimum of 8-10 years related experience.
Experience in IVD’s.
Experience in direct interactions with FDA.
Expert knowledge of scientific principles and concepts.
Gen-Probe offers a dynamic innovative work environment with excellent benefits, stock options & bonus potential, 401(k) w/company match, paid vacation/sick/holidays, continuing education, fitness center, and our own waterfall café.
View our Career Video!
http://www.view-career-video.com/videos/genprobe/
Learn about us and apply online by visiting:
http://www.gen-probe.jobs
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