Dynavax Technologies

  • Senior Statistical Programming Manager

    Job Location US-CA-Berkeley
    Posted Date 9 months ago(9 months ago)
    ID
    17-066R
    Category
    Clinical
  • Overview

    • This position will work collaboratively across clinical development and its external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Dynavax’s regulatory, scientific and business objectives.

    Responsibilities

      • Responsible for all programming activities within a therapeutic project or equivalent.

       

      • Supervise a team of contract statistical programmers.

       

       

      • Works collaboratively with Clinical Development staff to meet project timeline for statistical data analysis and reporting.

       

      • Generate or oversee the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.

       

      • Provide primary and secondary programming support as needed.

       

      • Ensure programming and corresponding documentation are completed in a manner that is consistent with departmental procedures and project deadlines.

       

      • Directs the design and/or coding of analysis files.

       

      • Write and/or review study data tabulation model (SDTM) data sets, analysis data sets (ADS), and report specifications prepared internally or by clinical research organizations (CROs).

       

      • Write and document development and validation programs to produce SDTM data sets, analysis data sets, and statistical outputs/reports.

       

      • Track and document program development/validation/production status.

       

      • Design, develop, and document software systems and code libraries to improve efficiency and quality.

       

      • Review statistical analysis plans and other relevant documents.

       

      • Write statistical programming standard operating procedures (SOPs) and work instructions.

       

      • Ensure compliance with SOPs, work instructions, ICH/GCP, and any other applicable local and international regulations.

       

      • Participate in internal/external audits and regulatory inspections as required.

       

      • Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

       

      • Other duties as assigned.

       

    Qualifications

      • BA/BS is required.

       

      • Strong SAS programming skills, including macros and statistical procedures.

       

      • Nine plus years of extensive experience in clinical trial statistical programming.

       

      • Must have proficient with CDISC SDTM and ADaM standards.

       

      • Must have a thorough understanding of clinical trial design, endpoints and reporting process, as well as regulatory reporting requirements including electronic data submissions.

       

      • Experience in oncology trials is highly desirable.

       

      • Strong knowledge of ICH/GCP.

       

      • Ability to work on multiple projects simultaneously and adjust to changing priorities.

       

      • Excellent verbal and written communication skills and interpersonal skills.

       

      Excellent organizational and project

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