Taiho Oncology

  • Sr. Manager, Statistical Programmer, Biostatistics

    Job Locations US-NJ-Princeton
    Category
    Biostatistics and Data Management
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. 

     

    The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, and managing CROs, implementing quality control process.

    Responsibilities

    • Effectively designs/develops SAS programs for ISS, ISE, clinical study reports, for regulatory submission, and for IB updates, DSUR, PSUR etc.
    • Validates/reviews statistical regulatory submission package (CDISC, SDTM, ADaM, define document, review guide etc.)
    • Supervises and manages CROs and contracted programmers to ensure quality performance and meeting of timelines
    • Develops complex SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required
    • Keeps management current on project status and provides ongoing risk assessments
    • Identifies problems and develops global tools that increase the efficiency and capacity
    • Organizes or participates technical meetings including internal and external representatives

    Qualifications

    Educational Requirements:

    • Bachelor/Master's Degree/in Biostatistics, Mathematics, Statistics, Computer Science, Life Science or equivalent

    Experience:

    • 9 years of relevant pharmaceutical industry work experience
    • Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials
    • Experience with regulatory submission, creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE
    • Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
    • Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards
    • Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry

    Other Skills and Abilities:

    • Good writing skills.
    • Highly detail and quality oriented.
    • A positive attitude, flexibility and a proactive thought process

    Language Skills:

    • Ability to read, analyze, and interpret common scientific and technical journals
    • Ability to effectively present information to top management

    Reasoning Ability:

    • Ability to define problems, collect data, establish facts, and draw valid conclusions
    • Ability to interpret a variety of technical instructions in mathematical form and deal with several abstract and concrete variables.

    Computer Skills:

    • Strong computer skills in industry standard statistical programming

    Physical Demands:

    • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
    • The employee is occasionally required to walk.
    • The employee must utilize close vision and be able to adjust focus.
    • Infrequent travel is anticipated

    Work Environment:

    • The noise level in the work environment is usually quiet

     

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The incumbent in this position may be required to perform other duties, as assigned.

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