Immunomedics, Inc.

Principal Biostatistician

Job Locations US-NJ-Morris Plains
Posted Date 3 months ago(1/7/2020 2:19 PM)
Job ID
# of Openings
Data Management


TheBiostatistician works directly with the medical project team to provide input into and insure the appropriateness of the statistical analysis methods described in the clinical study protocol. S/he develops statistical analysis plans consistent with the clinical trial primary safety and efficacy end points. The Biostatistician reports to the Director of Biostatistics.


  • Provides advanced input into the statistical sections and overall consistency of the clinical study report.
  • Develops and reviews statistical analysis plans.
  • Determines appropriate analysis for clinical endpoints based on the protocol and clinical team.
  • Responsible for the datasets and outputs for the clinical trial and insures their correctness, quality and consistency with the statistical analysis plan
  • Develops analysis (ADaM) dataset specifications to assist the statistical programming group in developing the datasets required for planned tables listing and figures.
  • Provide guidance for tables, listings and figures programming specifications as needed
  • Works with the data management team to review CRFs to insure that data collected meets the protocol requirements and helps insure data quality throughout the trial
  • Performs the preparation, execution, reporting and documentation of high-quality statistical analysis according to the statistical analysis plan
  • Responsible for statistical considerations in FDA submissions
  • Provides support to Data Safety Monitoring Boards by preparing and presenting the appropriate output
  • Generates sample size calculations appropriate for the primary endpoint based on the protocol
  • Prepares and reviews statistical methods and results sections for the clinical study report with the medical writers and clinical team
  • Generates and reviews randomization schedules per protocol and randomization schema
  • Assists in the development of project timelines, Standard Operating Procedures and guidance documents
  • Administrates as appropriate the receipt, collation and incorporation of review comments needed for completion of the statistical analysis plan, and result
  • Communicates competently and independently with the clinical team to coordinate statistical and programming activities of the project.


  • The ideal candidate will possess an advanced scientific degree MS in statistics or equivalent or PhD in statistics or equivalent.
  • 5 or more years of statistical analysis experience in the pharmaceutical or biotechnology industry or at a CRO preferably in oncology
  • Strong knowledge and experience in SAS (SAS STAT, SAS BASE, SAS MACROS, SAS/ODS and SAS GRAPH)
  • Strong knowledge of study design and statistical analysis methods (e.g. survival analysis techniques, summary descriptive statistics)
  • Working knowledge of SDTM/ADaM
  • Knowledge with ICH, GCP, and regulatory guidelines

Experience and Skills


  • Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time
  • Ability to work professionally and proactively with diverse team members
  • Excellent verbal and written communication and the ability to write and edit complex material to ensure accuracy clarity and effectiveness
  • Understanding of the drug development process
  • Self-motivated, hardworking, dependable and positive team-oriented personality
  • Ability to communicate effectively with statistical programmers
  • Current knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of eCTD requirements with respect to structure, format and content
  • Strong PC Experience and demonstrated proficiency with the MS Office Suite applications, Adobe Acrobat, and electronic document management systems


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