Senior Statistical Programming Manager

Location
Berkeley, CA
Posted
Nov 06, 2018
Ref
17-066R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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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