Principal / Associate Director Early Oncology Biostatistics

Permanent

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

Tagged as: Principal / Associate Director Early Oncology Biostatistics