Senior Biostatistician - Oncology

Company: Cepheid
Location: Santa Clara
Posted on: January 10, 2022

Job Description:

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 which makes everything possible.Are you a Biostatistician with experience supporting Oncology pre-clinical or clinical trials? We would love to talk to you!The Senior Biostatistician is responsible for planning, analysis and reporting of pre-clinical, clinical, and post-launch studies conducted by the Clinical Affairs teams.This position is part of the Data Management and Analytics Department and will be located in Sunnyvale, CA. Open to Remote for a very Senior level Statistician.In this role, you will have the opportunity to:

• Provide statistical input for study protocols and data collection instruments, develop statistical analysis plans, and compute sample sizes for pre-clinical, clinical, and post-launch studies, CE/IVD studies, and meta-analyses
• Support R&D with statistical input and advise as needed for biomarker selection, algorithm development, and analytical studies
• Write statistical analysis reports for various studies and regulatory submissions
• Stay current on product development issues and stages of clinical development by attending research review and development team meetings
• Consider the business needs in different clinical study design scenarios and educate the cross-functional team on how to improve prospects for future clinical studiesEssential Requirements
  • Masters or Ph.D. degree in statistics or biostatistics
  • Minimum of 2- 3 years of related work experience
  • Graduate-level knowledge of statistics including Survival Analysis, Logistic Regression, Multivariate Analysis, ANOVA, Categorical Data Analysis, and DOE
  • Must possess proficiency in statistical programming languages such as SAS and R.
  • Must be a proactive learner and adapt to new statistical methods and statistical software that are useful in oncology development.It would be a plus if you also possess previous experience in:
    • In-depth understanding of Kaplan-Meier Analysis, the Cox PH Model, and the Mixed Model gained through both training and work experience is mandatory for this position
    • Past experience with CE-IVD and FDA (510(k) and PMA) submissions.
    • Past experience supporting the design and validation of multiplex qPCR biomarker panels.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-JWWhen 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 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.
      
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      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 applyassistance@danaher.com to request accommodation.
      
      If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Santa Clara , Senior Biostatistician - Oncology, Healthcare , Santa Clara, California