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Senior Biostatistician in Sunnyvale, California at Cepheid

Date Posted: 5/19/2019

Job Snapshot

Job Description

Job ID: CEP003032

About Us

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).


Description

Overview:


The position will support clinical trials by developing statistical analysis plans for clinical trials and author the final statistical report.  This position will be point of contact for FDA questions pertaining to analysis.  The position will also assist in any supporting analysis such as precision and reproducibility studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity study carried out by development or the clinical trial group.

 
Responsibilities:

  • Develop Statistical Analysis Plans and Justify Sample Sizes for Alpha, Beta, Clinical Trials, and CE/IVD trials.     
  • Write final statistical analysis report for final submission to FDA.    
  • Maintain all statistical software licenses and ensure all statistical licenses are up to date.  This includes SAS, SAS JMP, and Minitab site licenses.  
  • Stay current on product development issues and stages of clinical trials by attending research review and development team meetings. Support R&D with statistical support and advise as needed.
  • Mentoring the junior/new junior biostatistics teammates in Excel & SAS or any other stat software.
  • Proactively communicate and protect the team & company's benefit.                

Job Requirements



Qualifications

Qualifications:

  • Master or Ph.D. in statistics or related field such as public health or epidemiology with strong statistical background
  • Minimum of 3 years of related work experience
  • Knowledge of statistics including DOE, Regression, Contingency Tables, Logistic Regression, Multivariate Analysis, ANOVA
  • Must have excellent written and verbal communication skills
  • Possess both  the Basic & Advanced SAS certificates through trainings, exams and prove in the working experience, preferred with SAS Stat programing experience
  • Can independently program in SAS (including Macro development) and learn how to document them in our real life submission (utilized in > 3 major submissions or projects successfully)
  • Can utilize Excel, SAS (required), & two more other stat software (JMP, Minitabs, R, etc.) and utilized them in the quality check

Preferred Qualifications: 

  • Certified Advanced programmer for SAS
  • Consider the business needs in different trial design scenarios and educate the cross functions on how to improve our chance of success for the future clinical trials

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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.