Karyopharm Therapeutics Inc.

  • Senior Data Scientist, Clinical Pharmacology

    Job Locations US-MA-Newton
    Job ID
    2019-1282
    # of Openings
    1
    Category
    Other
    Type
    Regular Full-Time
  • Responsibilities

    The successful candidate will have great understanding of data science. This individual will contribute to the Clinical Pharmacology components of clinical study design, clinical PK data interpretation and regulatory submissions.

     

    • Analyze bioanalytical Pharmacokinetic and Pharmacodynamics (PK/PD) data from clinical trials and prepare figures and tables using software eg. R, SAS.
    • Organize and build in-house PK/PD database. Use typical statistical approach to summarize and preform sub-group analysis on PK data across different studies. 
    • Perform statistical modeling analysis s (eg. Logistic regression modeling) on drug exposure, efficacy and safety data
    • Prepare slides/posters/report based on the PK/PD analysis
    • Manage and monitor bioanalytical labs, represent clinical pharmacology function to work with clinical operations, vendors and other relevant clinical functions on bioanalytical analysis.
    • Work closely with biostatisticians, programmers, clinical project managers and other scientists to support oncology clinical development
    • Support the contents preparation on clinical protocol and clinical pharmacology documents for regulatory submissions

     

    Qualifications

     

    • Masters or PhD Degree in Bioinformatics, Data Science, Biostatistics, Biomedical Engineering or related discipline; or a PharmD with good analytical skillset
    • 0 - 3 years’ experience in Life Science field; Preferably in oncology
    • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
    • Hands-on experience with R and/or SAS. Experiences on PK related software (WinNonlin, NONMEM, Monolix) are preferable 
    • Strong communication and project management skills
    • Ability to communicate analytical information to non-scientists
    • Ability to work in a fast-paced environment

    Overview

    Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019. 

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