Director, Biostatistics

San Francisco Greater Bay Area, East Bay
Feb 01, 2019
Required Education
Position Type
Full time

BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Director of Biostatistics to work for a leading Bay Area biotechnology company.


Director, Biostatistics


Work collaboratively with cross-functional teams to plan, conduct, analyze, and report pre-clinical and clinical studies to support U.S. and international registration applications. 


  • Lead statistical activities in support of product development and product registrations.
  • Collaborate with cross-functional teams and thought leaders in study planning (e.g., study design, sample size estimation, endpoint selection).
  • Responsible for statistical integrity and accuracy of data analysis.
  • Interact with FDA or other regulatory agencies in statistical aspects of study design, data analysis, and choice of statistical methodologies.
  • Author or review statistics section in protocols, statistical analysis plans (including definitions of derived variables and mock tables/listings), study reports, and DSMB charters.
  • Provide statistical advice and support to clinical researchers.
  • Provide quality oversight to CROs in activities related to statistical analysis and data management.
  • Work with department head to develop, implement, and maintain department standards and practices.


  • PhD in Biostatistics or Statistics with a minimum of 8 years experience in the pharmaceutical/biotechnology industry supporting clinical studies.
  • Proficiency with at least one major statistical software package (e.g., SAS, R).
  • Experience in CDISC data standards (e.g., SDTM, ADaM).
  • Strong attention to detail and accuracy.
  • Ability to integrate statistical and biomedical concepts.
  • Excellent communication skills with ability to interact across all levels and influence upwardly.
  • Time management skills (timelines, schedules, task prioritization).
  • Team player being able to adapt to changing priorities.