We are seeking a hands-on, experienced Senior Director, Biostatistics to lead and manage biostatistics deliverables in support of the company's clinical development programs. In addition, this position will guide broad clinical development strategy from the biometrics perspective and establish and manage relationships with vendors supporting biometrics activities. This is a full-time exempt position based at our corporate headquarters in San Diego, CA. ResponsibilitiesResponsible for the overall leadership and development of the Biostatistics departmentPrioritize activities and deliverables for the Biostatistics teamDevelop and drive statistical strategy across clinical programs and ensure the statistical soundness of the overall strategy and appropriateness of proposed study designsProvide input to design options, outcome measures, endpoint assessment, and sample size/power calculations during protocol developmentReview and author statistical sections of protocols, clinical study reports (CSR), and regulatory documentsDevelop and review statistical analysis plans (SAP)Utilize knowledge of industry standards for database and dataset design (CDISC: SDTM and ADaM)Collaborate with data management and programming functions to ensure optimal database design and buildSupport internal data review activities, e.g., Safety Assessment Committee, and external data review activities, e.g., independent data monitoring committeesLead biostatistics support for regulatory submissions, including writing and reviewing briefing documents, and provide responses to regulatory inquiries and represent Fate in interaction with Health AuthoritiesProvide statistical guidance to and oversight of biometric vendors and contracted personnelResearch statistical methodologies and statistical issues pertaining to design of clinical trialsStay current with FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug developmentLead departmental infrastructure development, including the development of statistical SOPs, processes, standards, and best practicesProvide independent programming for complex statistical analyses and visualizationContribute to presentations at scientific meetings and publication in peer-reviewed journals as the primary statistical authorMay manage and mentor junior staff members and/or external consultants as neededQualificationsMS or PhD in Biostatistics, Statistics, or closely related field12+ years of progressive and relevant experience in Biostatistics within the pharmaceutical or biotech industryTrack record of professional development with increasing levels of responsibility in the design and analysis of clinical trialSelf-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinkerAbility to work, lead and motivate a cross-functional matrix teamComprehensive knowledge of GCP, ICH ,CDISC and other pertinent regulatory guidanceDeep understanding of clinical development processStrong SAS and/or R programming experienceAdvanced knowledge of statistical methods and innovative clinical trial designAbility to conduct independent research and resolve statistical methodological issuesDemonstrated ability to manage competing priorities and deliver high-quality work under tight timelinesExperience in authoring and contributing to technical documents such as Statistical Analysis Plans, Clinical Study Reports, manuscripts, and abstractsExperience in managing or overseeing CROs and other external consultants and vendorsExperience with interacting with regulatory authorities Oncology and autoimmune clinical trial experience strongly preferred Experience or exposure to the development of cell therapies is desirableExcellent written and oral communication skillsWorking conditions & physical requirementsTravel may be required (upto20%)Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levelsCompensationThe salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.The anticipated salary range for this role is $250,000 to $275,000 per year. 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.
Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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AboutFate Therapeutics, Inc. Fate Therapeuticsis a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies.Fate Therapeuticsis headquartered inSan Diego, CA.For more information, please visitwww.fatetherapeutics.com.
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