Biostatistician

Bavarian Nordic - United States (30+ days ago)4.3


Title: Biostatistician
Reports to: Senior Manager, Biostatistics
Location: This is an on-site position in Morrisville, NC

Education Required: Master’s degree in statistics, biostatistics, or another relevant field

Experience Required: 3-5 years of experience at the master’s level (or higher) in the CRO or pharmaceutical setting

Additional Requirements:
  • Understanding of statistical methodologies used in clinical development
  • Strong SAS programming skills and can program analysis datasets and tables
  • Familiar with CDISC dataset requirements
  • Able to work well independently or as part of a team in high-pressure situations
  • Flexible and proactive working style, attention to details and ability to meet deadlines
Position Responsibilities:
  • Consults with clinical team on the design of studies, reviews and contributes to protocols as appropriate
  • Performs sample size computations in conjunction with clinical development staff
  • Develops statistical analysis plans and table, listing, and figure specifications for proposed trial protocols
  • Plans and specifies the structure of CDISC standardized datasets, including SDTM and ADaM data
  • Conducts planned and exploratory statistical analyses using a SAS
  • Validates and performs statistical review for SDTM data, ADaM data, displays, and reports
  • Ensures CDISC outputs meet standards, whether programmed internally or received from contractors
  • Manages external vendor deliveries, and ensures accuracy and quality deliverables
  • Interprets the results of planned and exploratory statistical analyses using written, oral, and graphic methods
  • Prepares statistical reports and displays for presentation at meetings or conferences, and for publication in regulatory documents or professional journals
  • Assists preparation of more senior biostatisticians for participation in agency meetings (i.e., FDA, EMA, PMDA)
  • Reviews clinical study reports for accuracy in interpretation of results