Dynavax Technologies

  • Senior Statistical Programming Manager

    Job Location US-CA-Berkeley
    Posted Date 11 months ago(12/12/2017 2:59 PM)
  • 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.


      • 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.



      • 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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