Abbott Director, Biostatistics in San Diego, California
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Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The Director of Biostatistics leads R&D statistical group in the Infectious Diseases Developed Markets Business Unit, providing statistical support for new product development, clinical trial design for pre- and post- market products. This lead role works closely with in R&D functions such as Medical Affairs, Scientific Affairs, Clinical Affairs, Assay Development, Software, as well as across BU functions such as Operations, Regulatory, Quality, Marketing and R&D. In this role, s/he will articulate strategy, develop plan, implement tools, recruit talent, and enhance statistical competencies to support a fast-growing Business Unit. Has strong leadership, demonstrate technical capability and positive experience with regulatory agencies. Can collaborate with statistical and quality engineering groups within Abbott to apply best practices. Can network with industry KOLs, adopt the latest innovative statistical approaches in point of care setting. Can guide design, characterization, verification, and validation of test method, process and clinical studies, playing a significant role in creating package insert and regulatory submission.
Possess deep knowledge, experience and skills related to the field of statistics applicable to the field of medical diagnostics.
Establish strategy to achieve business goals and meet customer’s needs by selecting statistical methodology, applying statistical tools, and providing statistical guidance to cross-functional team in R&D projects and clinical studies.
Work closely within R&D functions such as Medical Affairs, Scientific Affairs, Clinical Affairs, Assay Development, Software, collaborate across BU and Division with Operations, Regulatory, Quality, Marketing and R&D, outreach to external medical leaders and principal investigators.
Lead and be accountable for deliverables pertinent to statistical function: strategy and justification, statistical plans, database maintenance and statistical analyses for product development, clinical trials, on market product technical support, data for package insert and regulatory submission/update.
Oversee development and maintenance of statistical SOPs within the quality system.
Demonstrate commitment and exercise compliance with established business policies under quality management system.
Provide strategy and statistical plan to justify appropriate study design related to medical diagnostics, e.g., CLSI guidelines.
Uphold company and industry quality standards, guidelines and procedures.
Experienced in relevant regulations for clinical studies, data management, and statistics per ISO, FDA, and other regulatory agencies.
Familiar with product design, verification and validation, manufacturing and testing activities, and provide statistical guidance related to the quality testing of product.
Able to network with industry KOLs, adopt the latest innovative statistical approaches in point of care setting.
Ph.D. degree in statistics, biostatistics or related field with a minimum of 8 years of relevant experience.
Master’s degree in biostatistics with a minimum of 10 years of relevant experience.
Minimum of 8 years’ experience in the medical diagnostics industry (or equivalent), experience in the point-of-care setting is a plus
Strong programming skills in SAS or R (or equivalent)
Strong strategical thinking
Excellent statistical design and analysis capability
Excellent written and verbal communication skills
Experienced in managing staff, projects and collaborating with stakeholders.
Experienced in quality requirements for biostatistics, programming, and data management
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accomodation to qualified individuals with disabilities. To request accomodation, please send an email to MyRecruiter@alere.com.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org
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