At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
The primary emphasis of this position will be to work on clinical product teams throughout the lifecycle of the product from the product concept to regulatory submission and approval/clearance. Responsibilities include: planning and writing statistical sections of clinical protocols, performing and documenting statistical analyses (i.e. in SAS and other programs as appropriate) on clinical trial data and writing reports.
The successful candidate will need to stay current on statistical standards (e.g. CLSI, etc.) and trends in the in vitro diagnostic industry as well as FDA and other regulatory agencies.
- Support Oncology development through creation and verification of multiplex biomarker signatures. This can involve application of data mining, use of general linear modeling, and multivariate classification tools.
- Support Statistical Process Trending (e.g. control limits) tasks as needed to implement process improvement. Create OC and power curves for sampling plans.
- Manage audits of clinical data and perform SAS analysis of final data for statistical section of final report submitted to FDA or other regulatory agency.
- Review and update standard operating procedures for audits within the statistical department.
- Be an active member on product core teams throughout the product life cycle
- Will write statistical section for clinical protocols and reports, incorporating known risks and product requirements. Ensure team understands statistical risks of all sampling plans used.
- Provide statistical training/education programs to other teams as needed.
Qualifications - Required
- Bachelor’s Degree in Statistics or Biostatistics with 8 or more years of experience.
- Knowledge of statistics used in clinical trials and associated FDA and industry guidelines
- Relevant knowledge and usage of SAS, Excel, Minitab, S or R
- Excellent oral and written communication skills especially:
- Ability to express statistical ideas and concepts in ways understandable to non-statisticians
- Experience composing technical reports in English
- Ability to convert business, scientific, and engineering concepts into clear mathematical/statistical concepts and back again for implementation
Qualifications - Desired
- MS or PhD in Statistics or Biostatistics with 8 or more years of experience.
- Experience leading functional teams.
- IVD experience
Physical Demands: Not specified
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.