Director / Associate Director, Statistical Science

Location
San Diego, CA, United States
Posted
Sep 09, 2020
Ref
360HY
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

Fate Therapeutics is seeking a highly skilled and motivated statistician to serve as a statistical lead in our Biometrics Group. This individual will provide statistical oversight and expertise across a broad range of non-clinical areas, including drug discovery, pre-clinical studies, translational research, and all areas of Chemistry, Manufacturing and Controls (CMC). He or she will lead statistical support in the context of cross-functional collaboration and project-oriented effort. The position is responsible for promoting statistical thinking in the planning and execution of experimental study plans, leveraging scientific expertise and available technologies such as AI and machine learning to analyze data and extract insights. The ideal candidate should have in-depth knowledge in advanced statistical methods and strong expertise in non-clinical study design, analysis, and data mining. This is a full-time position reporting to the Vice President, Biometrics.

Responsibilities:
• Develop and drive statistical strategy to non-clinical programs and ensure the soundness of the overall strategy and appropriateness of experimental designs
• Collaborate cross-functionally to address issues related to study designs, biomarker discovery, assay development and optimization for PD, efficacy, PK and potential patient selection, process development and control, and statistical analyses and inferences
• Provide statistical review for scientific reports and publications, and regulatory documents such as IND/BLA filings
• Provide input for regulatory submissions and responses to regulatory inquires and represent Fate in interaction with Health Authorities
• Provide statistical guidance to biometrics vendors and contracted personnel
• Research statistical methodologies and statistical issues pertaining to experimental
design and data analysis
• Acquire knowledge outside traditional statistical domains in nonclinical areas and
incorporate as appropriate for internal projects
• Take initiative in assessing and introducing new/novel statistical study designs and
analysis strategies
• Stay current with FDA/EMA/ICH guidelines pertaining to non-clinical study design
and data analysis
• Contribute to the development of statistical SOPs and best practice
• Provide independent programming for complex statistical analyses and data
visualization
• Contribute to presentations at scientific meetings and publication in peer-reviewed
journals as the primary statistical author
• Develop and deliver statistical training curriculum for scientific organizations to
drive adoption of good statistical practice in study design and analysis
• Manage and mentor junior staff members as needed
• Take on other tasks as required

Qualifications
• Ph.D. in Biostatistics, Statistics or closely related field
• 7+ years (Associate Director) or 9+ years (Director) of progressive and relevant
experience in pharmaceutical or biotech industry
• Proven leadership skills in statistics from planning through implementation and
completion of non-clinical studies
• Knowledge of GLP, GMP, ICH, and other pertinent regulatory guidance
• Strong SAS and R programming experience
• Knowledge of CDISC SEND is desirable
• In-depth knowledge of statistical methodology and expertise in drug discovery,
translational research, CMC, and product commercialization
• Ability to conduct independent research and resolve statistical methodological
issues
• Demonstrated ability to manage competing priorities and deliver high-quality work
under tight timelines
• Experience in managing junior members of staff
• Excellent communication skills
• Strong team player
• Experience of interacting with regulatory authorities highly desirable
• Experience in leading non-clinical activities preferred
• Collaborative teamwork and interpersonal skills that demonstrate initiative and
motivation

Working Conditions and Physical Requirements
• Occasional evening and weekend work will be required The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job 360HY.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being

evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.