US-CA-San Diego: Biostatistician
http://biotech.fyicenter.com
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Date: 02-Sep-2008
Biostatistician
DESCRIPTION OF POSITION RESPONSIBILITIES:
* Manages resources, project priorities and timelines for assigned
clinical trials. * Participates in strategy development and
contingency planning. * Designs, documents, tests and implements
complex statistical analysis methods in collaboration with Clinical
Affairs and other departments. * Works with the Clinical Affairs
project team on CRF design to ensure data meets analysis needs. *
Works with database development team to ensure that database design
meets analysis needs. * Provides input on Data Management SOPs and
provides primary input on Biostatistical SOPs and work instructions. *
Develops statistical programs for data analysis and data presentation;
works with SAS programmers to ensure appropriate analysis data
analysis and presentation is performed. * Writes complex Statistical
Analysis Plans (SAPs) * Develops table/listing/graph shells for
complex statistical analyses and reports. * Writes the statistical and
data analysis sections in the regulatory submissions. * Acts as a
statistical consultant to solve statistical problems for other
departments (R&D, QA, QC, Marketing and Manufacturing). * Interfaces
with clinical investigators and scientists to determine protocol
design. * Ensures integrity of data reports, listings and statistical
analyses that support regulatory submissions. * Act as contributor to
FDA (and other regulatory) interactions regarding experimental design
and statistical analysis.
RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
* Advanced knowledge of CRF and database development, including
attribute assignment and logic checking. * Advanced knowledge of
statistical software packages such as SAS and/or S-Plus. * Expert
knowledge of common and advanced statistical theory and methods for
clinical trials, design of experiment and quality control. * Knowledge
of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
* Knowledge of statistical method for quality control. * Knowledge of
infectious disease, cancer, genomics and common public health issues.
* Experience in technical writing. * Excellent communication skills
(verbal and written). * Ability to work independently. * Ability to
work with senior-level cross-departmental colleagues to develop
practical strategies for study design and FDA interaction based upon
sound and accepted statistical principles. * We are looking for a very
strong candidate who is proven and will hit the ground running.
EDUCATION AND EXPERIENCE REQUIREMENTS:
* Requires a PhD in Statistics/Biostatistics or equivalent in
engineering and a minimum of 8-10 years related experience. *
Experience in IVD’s. * Experience in direct interactions with FDA. *
Expert knowledge of scientific principles and concepts.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/