Principal Biostatistician

Principal Biostatistician Job Description Template

Our company is looking for a Principal Biostatistician to join our team.

Responsibilities:

  • Generates sample size calculations appropriate for the primary endpoint based on the protocol;
  • Provide guidance for tables, listings and figures programming specifications as needed;
  • Determines appropriate analysis for clinical endpoints based on the protocol and clinical team;
  • Develops and reviews statistical analysis plans;
  • Generates and reviews randomization schedules per protocol and randomization schema;
  • Provides support to Data Safety Monitoring Boards by preparing and presenting the appropriate output;
  • Provides advanced input into the statistical sections and overall consistency of the clinical study report;
  • Communicates competently and independently with the clinical team to coordinate statistical and programming activities of the project;
  • 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;
  • Assists in the development of project timelines, Standard Operating Procedures and guidance documents;
  • Prepares and reviews statistical methods and results sections for the clinical study report with the medical writers and clinical team.

Requirements:

  • Masters-level degree in Statistics, Biostatistics or related field with eight years relevant CRO industry or biotech experience; or;
  • Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience;
  • Knowledge with ICH, GCP, and regulatory guidelines;
  • The ideal candidate will possess an advanced scientific degree MS in statistics or equivalent or PhD in statistics or equivalent;
  • Strong knowledge and experience in SAS (SAS STAT, SAS BASE, SAS MACROS, SAS/ODS and SAS GRAPH);
  • Working knowledge of SDTM/ADaM;
  • 5 or more years of statistical analysis experience in the pharmaceutical or biotechnology industry or at a CRO preferably in oncology;
  • Education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field;
  • Strong knowledge of study design and statistical analysis methods (e.g. survival analysis techniques, summary descriptive statistics);
  • Solid knowledge in global regulatory guidance documents and requirements.