• Sr Manager Biostatistics

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1266
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Product Development
    FLSA Status
    Exempt
    Work Shift
    N/A
  • Overview

    Work closely with the other members of the Product Development Team: Clinical Operations, Regulatory, and Clinical Pharmacology to ensure highest quality of the statistical and data management deliverables that would contribute to the successful development of new products and/or improvement of existing products of the company. 

     

    Provide original contribution in programs development and scientific research by leading and validating deliverables from CROs to ensure alignment with current FDA requirements and ready for submissions.

    Responsibilities

    • Review and contribute to the statistical and data management documents: statistical sections of protocols, data management plan, edit checks, clinical study reports, etc.
    • Ensure the proper collection, management, and storage of clinical trial data
    • Review Case Report Forms and validate database development by conducting User Acceptance Test (UAT)
    • Review Statistical Analysis Plans (SAP), and lead CRO with the development of study specific dataset specifications
    • Validate the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents) delivered by CROs
    • Validate key statistical analysis delivered by CROs
    • Reviews Tables, Listings and Figures delivered by CROs and resolve problems through the productive communications
    • Support submission strategy planning through the communication with regulatory
    • Be an expert of current CDISC (Clinical Data Interchange Standards Consortium) and the FDA Guidance for submission
    • Provide time and resource estimates for statistical deliverables from CRO
    • Contribute to the in-house post-hoc and exploratory analyses when needed
    • Assist, validate and/or generate randomization schedules when needed

    Qualifications

    Competencies:

    • Dive Deep - demonstrate deeper professional expertise by having more complex expectations and deliverables
    • Earn Trust - enhance collaboration with CROs by gaining trust thought the listening and negotiating good quality common deliverables 

    Education & Experience:

    • A Master’s degree in medical, scientific, biological, statistics, computer science, or related field is preferred
    • Seven years of experience in Pharma / Biotech industry
    • Experience and understanding different Phases of Clinical Trials
    • Data management and case report form (CRF) design experience is a plus
    • General knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
    • Knowledge of SAS programming and other significant statistical software (e.g., S-Plus, PASS)
    • Knowledge of regulatory guidance documents, such as ICH guidance documents
    • Knowledge of clinical study designs and modern statistical methodologies
    • Written and oral communication skills
    • Be a team member and work with cross functional teams is essential

     

    Judgment / Decision Making:

     

    Work Environment:

    Office environment operating a computer

     

    Physical Demands:

    Visual acuity and manual dexterity to operate a computer and proofread documents

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