Dynavax Technologies

Senior Statistical Programming Manager

Berkeley, CA
Oct 07, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time


  • 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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