Senior Manager / Manager, Biostatistics

Location
San Diego, CA
Posted
May 19, 2022
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Fate Therapeutics is seeking an experienced and motivated statistician to serve as statistical lead in our Biometrics Group. This individual will provide statistical oversight and technical expertise to Fate’s clinical studies. The successful candidate collaborates cross-functionally with Clinical Development, Clinical Operations, Clinical Translation, Regulatory Affairs, and Quality Assurance teams. The ideal candidate should have in-depth knowledge in advanced statistical methods and strong expertise in innovative study designs of oncology and hematology-oncology clinical trials. This is a full-time position reporting to the Director of Biostatistics, and is located at our corporate headquarters in San Diego, CA or at our offices in South San Francisco.  
Responsibilities
  • Work independently as a lead statistician for one or more clinical studies to provide statistical oversight and expertise.
  • Lead, develop, and coordinate biostatistical activities for Clinical Development, Clinical Operations, Clinical Translation, and Regulatory Affairs.
  • Provide input to study 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 author statistical analysis plans (SAP) for CSR and integrated summaries. 
  • Be responsible for statistical aspects of internal governance reviews.
  • 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. 
  • Provide input for regulatory submissions and responses.
  • Participate in vendor selection for Biostatistics, Data Management, and Statistical Programming.
  • Evaluate and implement innovative statistical techniques for clinical trial design and data analysis.
  • Stay current with FDA/EMA/ICH guidelines for statistics and clinical development.
  • Participate in the development of statistical SOPs and best practices.
  • Provide independent programming for complex statistical analyses and visualization. 
  • Contribute to presentations at scientific meetings and publication in peer-reviewed journals. 
  • Manage and mentor junior staff members as needed. 
  • Take on other tasks as required. 

Qualifications
  • PhD in Biostatistics, or other quantitative discipline with 3+ years of experience in the pharmaceutical/biotech industry or regulatory agencies, or MS with 5+ years of experience. 
  • Experience as an independent lead statistician for multiple studies or projects.
  • Knowledge of GCP, ICH, CDISC and other pertinent regulatory guidance. 
  • Strong SAS and 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.
  • Excellent communication skills. 
  • Excellent project management skills.
  • Experience of interacting with regulatory authorities highly desirable.
  • Oncology clinical trial experience strongly preferred. Early-phase Phase 1 oncology experience a plus.
  • Ability of managing CRO and external vendors.
  • Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation.

Working Conditions and Physical Requirements
  • May require occasional evening and weekend work. 
  • Full-time onsite work at Company’s headquarters in San Diego or in South San Francisco, California. 

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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. 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 pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.