Penfield Search Partners
Principal/Associate Director Biostatistics
Location: Greater San Francisco
Contact Susan Devine – sdevine@penfieldsearch.com
Oncology is a key therapeutic area for our client, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules in immuno-oncology, stem cells, and cell-signaling. They are seeking an experienced Biostatistician to provide statistical support and development strategy for clinical research programs.
Ensure consistency among protocols and work with the project team to select
appropriate study designs to meet study objectives
Independently determine appropriate statistical methodology needed in
support of study objectives; develop and author the statistical methods section
of the protocol
Work with external partners, including CROs, drug supply, and other groups,
to effectively implement the randomization schedule as planned
Actively participate in meetings to identify scientifically appropriate data
collection instruments and database design requirements to ensure that the data
evaluated are free of bias, contain maximum information (minimum variance), and
satisfy analysis requirements
Evaluate alternative statistical approaches, to make recommendations based
on sound statistical reasoning, and to influence non-statisticians to accept the
analytical approach
Develop analysis plans, ensuring statistical methods and corresponding
details are appropriate and sound, consistent with protocol study design,
and sufficiently detailed for programming implementation.
Ensure internal consistency of analysis plans for assigned studies/projects.
Analyze data from clinical trials or scientific experiments to meet
objectives of the study protocol
Work with project team to develop strategy for data presentation and
scientific arguments
Prepare oral and written reports that effectively communicate results of
scientific research to the project team, management, regulatory agencies, or
individual investigators
Represent Biometrics on assigned project team to provide functional area
input to compound/drug development.
Serve as a liaison between the project team and Biometrics to ensure timely
communication of project team updates, proper statistical strategies, and
alignment of priorities between the project team and functional area
Maintain technical skills and increases own knowledge of new statistical
methodology or areas of application through use of the scientific literature and
attendance at professional meetings
Present own statistical research or review of the statistical literature at
meetings and seminars
Effectively and persuasively present statistical concepts, evidence,
assessment of risks and impacts, and logical arguments to management, regulatory
agencies, and scientists.
Perform peer review for protocol, analysis plan, study report, and other
major deliverables, publications
Desired for the role:
MS or PhD in Statistics, Biostatistics or a highly related field. At least
4-6 years (PhD) or 8-10 years (MS) of experience in pharmaceutical development
in industry