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Danaher Corporation Senior Biostatistician, Oncology in Sunnyvale, California

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.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Sr. Biostatistician for Cepheid, leader in molecular diagnostics, is responsible for statistical input and guidance during assay development supporting data analysis and reporting of pre-clinical, clinical, and post-launch studies.

This position is part of the Oncology R&D department and will be located at Cepheid, in Sunnyvale, CA or REMOTE preferably someone that can come into the office on occasion. This position will be the point of contact for R&D and a cross functional Biostatistics core team on questions pertaining to statistical analysis supporting both development activities and post-launch studies.

You will be a part of the Solid tumor program in Oncology R&D and report to the Director of Assay Development, responsible for developing and executing statistical analysis in support of the development of Point of Care molecular diagnostic tests.

If you thrive as a self-driven, independent, focused contributor in a multifunctional, fast paced, innovative role and want to work to build world-class Oncology diagnostics products in our dynamic organization—read on.

In this role, you will have the opportunity to:

  • Independently support and guide R&D teams by developing statistical analysis plans for assay performance studies, conducting metanalysis of clinical study data and authoring statistical reports.

  • Support statistical 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.

  • Develop Statistical Analysis Plans for Alpha, Beta, Clinical Trials, and CE/IVD trials.

  • Write statistical analysis report for final submission to FDA.

  • Stay current on product development issues and stages of clinical trials by attending research review and development team meetings.

    The essential requirements of the job include:

  • Bachelor’s degree with 5+ years of experience OR Master’s degree with 3+ years of experience OR PhD with 0-2 yrs of experience

  • A deep understanding of statistical methods such as Survival Analysis, Logistic Regression, Multivariate Analysis, ANOVA, Categorical Data Analysis, and DOE

  • Past experience in R&D supporting the design and validation of multiplex biomarker panels.

  • Must have excellent written and verbal communication skills and possess proficiency in statistical programming languages such as SAS and R.

  • Past experience with CE-IVD and FDA (510(k) and PMA) submissions

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

  • Advanced degree with 5+ years of experience (preferably in the industry), in statistics, biostatistics or other scientific related degree.

  • Experience with analysis of real world / investigator-initiated study datasets, including meta-analyses of pooled datasets.

  • Understanding of Kaplan-Meier Analysis, and Survival Models gained through both training and work experience

  • The Basic & Advanced SAS certifications are not required but preferred.

Cepheid, a Danaher 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.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

#LI-REMOTE

#LI-JW1

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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