Dynavax Technologies

Senior Statistical Programmer/Clinical Programming

Berkeley, California
May 15, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

  • 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.
  • 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.