- 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.
- 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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