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Principal Biostatistician in Sunnyvale, California at Cepheid

Date Posted: 1/11/2019

Job Snapshot

Job Description

Job ID: CEP002549

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

  • Job Description Summary
    Develops and employs computational tools to analyze
    biological data. Collects, organizes, analyzes and interprets
    data including nucleotide and amino acid sequences, protein
    domains, and protein structures to seek biological insights.
    Designs, plans and executes biostatistical components of
    plans for research and development projects that establish
    the conditions essential for determining safety, efficacy,
    and marketability of biological products. Develops and/
    or applies statistical theories, methods, and software.
    May collaborate in the production of the study protocols,
    and the collection, management and/or reporting of data.
    Develops automated data analysis pipelines and laboratory
    information management systems. Provides software and IT
    support for laboratory information management systems.
  • Job Description

    Overview:

    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.

    Responsibilities:

    - 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.

Job Requirements



Qualifications

Qualifications - External

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 6 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.