Senior Director, Biostatistics

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.

Responsibilities

• Responsible for the overall leadership and development of the Biostatistics department
• Prioritize activities and deliverables for the Biostatistics team
• Develop and drive statistical strategy across clinical programs and ensure the statistical soundness of the overall strategy and appropriateness of proposed study designs
• Provide input to design options, outcome measures, endpoint assessment, and sample size/power calculations during protocol development
• Review and author statistical sections of protocols, clinical study reports (CSR), and regulatory documents
• Develop 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 build
• Support internal data review activities, e.g., Safety Assessment Committee, and external data review activities, e.g., independent data monitoring committees
• Lead biostatistics support for regulatory submissions, including writing and reviewing briefing documents, and provide responses to regulatory inquiries and represent Fate in interaction with Health Authorities
• Provide statistical guidance to and oversight of biometric vendors and contracted personnel
• Research statistical methodologies and statistical issues pertaining to design of clinical trials
• Stay current with FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development
• Lead departmental infrastructure development, including the development of statistical SOPs, processes, standards, and best practices
• Provide independent programming for complex statistical analyses and visualization
• Contribute to presentations at scientific meetings and publication in peer-reviewed journals as the primary statistical author
• May manage and mentor junior staff members and/or external consultants as needed

Qualifications

• MS or PhD in Biostatistics, Statistics, or closely related field
• 12+ years of progressive and relevant experience in Biostatistics within the pharmaceutical or biotech industry
• Track record of professional development with increasing levels of responsibility in the design and analysis of clinical trial
• Self-motivation, good judgment, strong follow up, organizational, analytical, and problem-solving skills; capable of identifying risks; creative and innovative thinker
• Ability to work, lead and motivate a cross-functional matrix team
• Comprehensive knowledge of GCP, ICH ,CDISC and other pertinent regulatory guidance
• Deep understanding of clinical development process
• Strong SAS and/or R programming experience
• Advanced knowledge of statistical methods and innovative clinical trial design
• 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 authoring and contributing to technical documents such as Statistical Analysis Plans, Clinical Study Reports, manuscripts, and abstracts
• Experience in managing or overseeing CROs and other external consultants and vendors
• Experience with interacting with regulatory authorities 
• Oncology and autoimmune clinical trial experience strongly preferred 
• Experience or exposure to the development of cell therapies is desirable
• Excellent written and oral communication skills

Working conditions & physical requirements

• Travel may be required (upto20%)
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels

Compensation

• The 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