Back to Job Search

Director/ Sr. Director of Biostatistics

  • Location: San Francisco
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Life Sciences
  • Contact: Alicia Licht
  • Expiry Date: 23 October 2022
  • Job Ref: JN -092022-473716

Sr. / Director, Biostatistics

Responsibilities:

  • Responsible for applying relevant statistical methods to the practice of clinical data summaries and interpretations
  • Lead and mentor junior team members
  • Represent Company statistical function to work with Health Authorities and Key Opinion Leaders as needed
  • Provide strategic and technical input into drug development plan; work with cross-functional team to design and operationalize clinical studies; provide statistical input in the evaluation, interpretation, and preparation of study results
  • Be accountable and responsible for statistics deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, etc.
  • Select, manage, and supervise CROs.
  • Create standard SAS programs and macros to generate report-quality summary tables, listings and graphical presentations of clinical data.
  • Prepare programs for creating analysis data sets and associated tables, listings, and graphs used for interim analyses, final analysis, press releases, and presentations and publications
  • Understand CDISC structure for datasets and ability to merge relational database records
  • Review and provide appropriate input to the design of Case Report Forms or Electronic Data Capture screens
  • Review clinical data for inappropriate, incorrect, and/or inconsistent values
  • Develop and program electronic checks to assist data management and clinical with monitoring and scrubbing of clinical trial data as needed
  • Assist with resolution of unique queries that may arise during the data management and statistical analysis process
  • Provide ad-hoc data listings and summary information as requested by members of the BDM and Clinical groups
  • Conduct ad hoc and exploratory analysis to unveil signals contained in clinical trial data
  • Lead and participate in developing and maintaining relevant BDM processes to ensure quality of study data and accuracy of statistical outputs
  • Perform quality control with respect to the data to be analyzed and the programs to be used for the analysis
  • Define processes and perform additional (alternative) quality checks focusing on key efficacy and safety endpoints to ensure validity of data and accuracy of analyses.
  • Continue to improve the quality process to ensure the growing requirement of data and output validations
  • May be responsible for supervising and mentoring direct report(s)
  • Managing / supporting the preparation of data package for NDA and other regulatory submissions
  • Adhere to the standard computer directory and file structures used within the BDM group and Clinical department

...