PRINCIPAL BIOSTATISTICIAN Job In San Francisco, CA, United States On ScientistCrossing

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Job Title
PRINCIPAL BIOSTATISTICIAN

Job Profile
The Principal Biostatistician is responsible for providing statistical support for the design, conduct, analysis, and reporting of Phase 1-3 clinical trials. This individual will work interactively with statistical programming, data management, clinical, and regulatory personnel. He/she will informally direct statistical programmers, and may coordinate the work of junior or contract biostatisticians. The primary responsibilities of this position include: evaluation of study design; sample size calculation; protocol statistical methods; evaluation of case report forms; specification of high-level data edit checks; development of statistical analysis plans; interim and final analyses; report writing and review; ensuring cross-study consistency in design and analysis; support of publications and presentations; statistical input into clinical development strategy; interaction with regulatory agencies; preparation and defense of regulatory submissions;
and supervision of work by contract research organizations.
Requirements
A MS and 8 years experience in clinical development in the pharmaceutical industry or a PhD and 5 years experience are required. The successful candidate will have considerable experience in study design and analysis, as well as experience in the preparation and/or defense of regulatory submissions; proficiency with SAS statistical procedures and basic familiarity with use of R software; solid understanding of clinical trial principles, and an understanding of regulatory requirements. He/She must also be flexible and work well within a dynamic, interdisciplinary, small company environment.
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Location: USA-CA-San Francisco

Posted on
Jun 18,2026

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