Cepheid

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Biostatistician will primarily provide comprehensive statistical support for clinical studies in molecular diagnostic product development. This

position will be a point of contact for related statistical questions from regulatory agencies (FDA/CE). The position will also assist Research &

Development teams in statistical analysis of analytical studies. On occasion, the position will provide statistical consultation to Quality and

Manufacturing teams.

This position is part of the Clinical Affairs department and will be located in Solna, Stockholm, Sweden.

In this role, you will have the opportunity to:

• Provide sample size estimations for various clinical and analytical studies.
• Develop detailed statistical analysis plans for clinical studies.
• Conduct appropriate statistical analysis such as categorical analyses, regression analyses, ANOVA, and ROC analysis.
• Provide statistical analysis support to R&D teams for analytical studies such as reproducibility and precision, limit of detection/quantification (LoD/LoQ), and linearity.
• Provide statistical consultation to Quality and Manufacturing teams regarding design of experiments (DOE) and control limit specifications.
• Develop and maintain up to date knowledge on statistical software such as SAS, R, JMP, Minitab, and PASS
• Stay current on statistical issues pertaining to diagnostic development and stages of clinical studies by attending research review and development team meetings.

The essential requirements of the job include:

• Degree in statistics/biostatistics or related field such as public health or epidemiology with strong statistical components.
• Statistical programing expertise in either SAS or R.
• Knowledge of statistics including DOE, Regression, Contingency tables, Logistic regression, Multivariate analysis, ANOVA, Mixed models, and ROC.
• Excellent written and verbal communication skills in English.

It would be a plus if you also possess previous experience in:

• Certified Base programmer for SAS or equivalent competency in R.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.