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    Opportunity: Director/Associate Director of BIOSTATISTICS @ Nodality--South San Francisco, CA (US)
    Submitted by David Spellmeyer; posted on Friday, February 06, 2009

    BACKGROUND

    We are looking for a Biostatistician with a minimum of 4 years of experience supporting development and commercialization of diagnostic tests, medical devices, therapeutics or related fields.

    Nodality is a venture capital-funded biotechnology company headquartered in South San Francisco, CA, with laboratories in Franklin, TN. We are dedicated to using advanced biological characterization technology to improve the treatment of patients with cancer. The company's initial primary areas of focus include hematological malignancies and autoimmune disorders.

    Nodality's proprietary flow cytometry technology was developed in the laboratory of Professor Garry Nolan and licensed from Stanford University. At Nodality this technology has been taken to the next level, utilizing advanced quantitative flow cytometry to characterize the signaling networks within individual cancer cells in order to enable biologically-driven clinical decision making for cancer treatment.

    Nodality has a strong internal discovery research capability supported by numerous academic interactions, and has recently made strong hires to strengthen clinical development, intellectual property management, regulated product development, business development and marketing. The company is on track to commercialize its first tumor biological characterization products in clinical lab tests by the end of 2009.

    EXPERIENCE

    The successful candidate will have demonstrable experience with:
    • Data analysis on clinical studies of diagnostics or therapeutics
    • Statistical considerations of clinical studies
    • Working on a cross-functional team, including clinicians, biologists, bioinformatics and product support
    • Delivering statistical work product on aggressive timelines
    • Proposing and performing appropriate statistical analyses for hypothesis generation and testing

    RESPONSIBILITIES

    • Contribution to clinical study design, protocols and study reports preparation
    • Work closely on a team of clinical statisticians, clinicians, biologists, and informaticians
    • Prepare statistical analysis plans
    • Perform statistical analyses, including generation of clinical study data summaries and ad-hoc reports
    • Accurately estimate time lines and resources needed to meet project team objectives
    • Participate in development and testing of novel QA/QC metrics for instrumentation and reagent development, qualification
    • Work closely with research informatics scientists on development and testing of novel metrics for flow cytometry data analysis and other instrumentation
    • Ensure completeness, correctness and integrity of analyses and datasets
    • Support clinical & medical affairs, product development, launch, and marketing effort

    REQUIREMENTS

    • Excellent interpersonal skills and a demonstrated expertise in team-oriented environments
    • Good problem solving skills and excellent verbal and written communication skills are required
    • A minimum of 4 years of statistical programming experience in the biotech/pharmaceutical industry environment
    • Ph. D. degree in statistics or related field
    • Demonstrated willingness to be hands-on and pro-active
    • Proficiency in statistical programming environments such as SAS, R, or S-Plus
    • Familiarity with other programming languages, especially Python, is a plus
    • Able to multitask, work independently, and set own priorities, while maintaining accuracy and attention to details
    • Comfortable in a dynamic, rapidly changing, and highly competitive industrial environment
    • Able to work effectively with internal and external colleagues and collaborators, both academic and industrial
    • Ability to exercise mature judgment
    • Thorough knowledge of the basic concepts, principles, and theories of management and the ability to understand the managerial policies applicable to the organization

    LOCALE

    Based in South San Francisco, California. Travel to our Franklin, TN, laboratories is expected on occasion.

    COMPENSATION

    Nodality offers a competitive salary and benefits package including flexible time off, health, dental, vision, long-term disability and life insurance, as well as equity participation and participation in the Company’s 401(k) plan.

    HOW TO APPLY

    Candidates must submit: (1) a resume and (2) a letter of application which addresses qualifications, skills, and experience necessary to perform the duties. Applications submitted without both items will not be considered. Only applicants selected for an interview will be notified.

    Principals only. No recruiter/agency solicitations will be answered unless a contract for this specific position is already in place.

    Application materials should be marked "confidential" and either:

    e-mailed to: jobs[at]nodalityinc.com

    or

    mailed to:
    Human Resources
    Nodality
    201 Gateway Blvd
    South San Francisco, CA 94080

    No phone calls please.

    Nodality is an Equal Opportunity Employer.

    Privacy Notice: We will save your name, resume, and the email address you have submitted so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.

    Employees must be United States citizens or eligible to work in the United States.

    Nodality reserves the right to modify the conditions of this job announcement, to withdraw the announcement, or to fill the position sooner than the closing date, any of which may occur without prior written or other notice. In accordance with California law, employment is at will.

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