Fate Therapeutics, Inc.

Fate Therapeutics, Inc.

Senior Manager, Biostatistics

San Diego, CA · Senior · Full-time

Sponsorship not specified$145k-$180kDetected 4 days ago
GCPStatisticsProject ManagementRecruitingClinical TrialsSASExperimental DesignLeadershipCommunicationBiostatistics

About the role

  • This position requires solid technical and communication skills, and the ability to work independently with moderate guidance.
  • This is a full-time position reporting to the Executive Director, Biostatistics and is located at our corporate headquarters in San Diego, CA location.
  • The preceding job description indicates the general nature and level of work performed by employees within this classification.

Responsibilities

  • Provide sound statistical and operational input in protocol design, outcome measures, and sample size justification.
  • Develop statistical analysis plans, mock shells, programming specifications, and other key trial documents.
  • Perform and validate statistical analyses of clinical trial data to ensure timely and accurate reporting.
  • Support study setup activities including EDC design and testing.
  • Support data review activities, including and not limited to Safety Assessment Committees, Data Monitoring Committees, Adjudication Committees.
  • Collaborate with cross-functional teams such as clinical development, clinical operations, data management, regulatory, translational science, and quality assurance, to ensure statistical integrity and compliance.

Requirements

  • PhD in Statistics or related scientific field with 4+ years of relevant experience in the pharmaceutical/biotech industry, or MS with 7+ years of experience.
  • Strong knowledge of statistical concepts and techniques used in clinical development.
  • Knowledge of GCP, ICH, CDISC and other pertinent regulatory guidance.
  • Travel may be required (up to 10%).
  • Strong SAS programming experience.
  • Demonstrated ability to manage competing priorities and deliver high-quality work under tight timelines.
  • Excellent communication and project management skills.
  • Oncology and/or autoimmune disease clinical trial experience strongly preferred. Early-phase disease experience a plus.
  • Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation.
  • Working conditions & physical requirements
  • Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Nice to have

  • Oncology and/or autoimmune disease clinical trial experience strongly preferred.
  • Early-phase disease experience a plus.

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 $145,000 - $180,000.

Equal opportunity

  • Fate Therapeutics, Inc. is an equal opportunity employer.
  • We value diversity and are committed to creating an inclusive environment for all employees.
  • About Fate Therapeutics, Inc.
  • Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients.
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