Dynavax Technologies

  • Manager, Statistical Programming

    Job Location US-CA-Berkeley
    Posted Date 4 months ago(12/12/2017 2:59 PM)
    ID
    17-066R
    Category
    Clinical
  • Overview

    Supports all clinical trial statistical programming activities, including writing and reviewing specifications, developing SAS programs to create CDISC-conforming data tabulations and analysis datasets and generate statistical outputs such as tables, listings and figures, reviewing and validating programmed datasets as well as statistical outputs produced in-house or by contract research organization (CRO) products, and coordinating the work of other statistical programmers.

    This position may provide technical and project oversight of contract programmers.

    Responsibilities

    • Writes and documents development and validation programs to produce study data tabulation model (SDTM) data sets, analysis data sets (ADS), and statistical outputs/reports.
    • Tracks and documents program development/validation/production status.
    • Writes or reviews SDTM, ADS, and report specifications prepared internally or by CROs.
    • Designs, develops, and documents software systems and code libraries to improve efficiency and quality.
    • May supervise the work of other statistical programmers.
    • Reviews statistical analysis plans and other relevant documents.
    • Writes statistical programming standard operating procedures (SOPs) and work instructions.
    • Contributes to the development of plans and timelines for internal and CRO work.
    • Ensures compliance with SOPs, work instructions, ICH/GCP, and any other applicable local and international regulations.
    • Participates 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. MA or MSc in statistics/biostatistics or a related discipline is highly desirable. 
    • Strong SAS programming skills, including macros and statistical procedures.
    • Extensive experience in clinical trial statistical programming.
    • Has a thorough understanding of clinical trials design, endpoints and data process.
    • Knowledge of ICH/GCP.
    • Knowledge of CDISC SDTM and ADaM standards.
    • 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 management skills and attention to detail.
    • Effective working within a cross-functional team and highly collaborative.

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