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Head of Biometrics

Adicet Bio, Redwood City, California

Position Description:

Adicet Bio, Inc is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CAR) and T cell receptor-like antibodies (TCRL), to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. For more information, please visit our website at http://www.adicetbio.com.

HEAD OF BIOMETRICS

The newly created role of Head of Biometrics will be responsible for creating and implementing the strategic direction for biostatistics, real world evidence, programming, and data management collection activities across Adicet’s pipeline, and for ensuring that proper statistical analyses and interpretations are carried out. S/he will be responsible for developing functional infrastructure and building the biometrics capabilities and, in collaboration with the Heads of Clinical Development & Regulatory Science, will influence the long-term strategic direction for Biometrics. The Head of Biometrics will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.

Duties and Responsibilities:

  • Develop, implement and drive evolution of Adicet’s statistics and data management capabilities
  • Serve as a strategic partner working closely with study team and program teams in providing statistical input to clinical development plans and trial designs
  • Serves as the point of escalation for all biometric functions to ensure the timeliness and accuracy of biometric deliverables
  • Provide support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (e.g., advisory panels or other meetings)
  • Present analyses to internal and external audiences (e.g., regulatory agencies, collaborators, investigators, vendors, alliance partners, etc.)
  • Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures, either directly or through management of CROs
  • Provide expert statistical review/QC and input into statistical deliverables (i.e., analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.e., database design, critical data checks and validation)
  • Provide input on relevant sections of research protocols and regulatory documents including endpoint specification, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)
  • Oversee the operations and procedures for the collection, editing, verification and management of data
  • Manage data extraction and data listings; reviews and participates in QC and finalization of various documents, including abstracts, posters, manuscripts, publications, press releases, study reports, regulatory documents, etc.
  • Provide leadership to team members including managing performance, developing people, hiring and integrating new team members and fostering Adicet’s culture, mission, vision and values.

Qualifications:

Education and Experience:

  • PhD in statistics or related field; candidates with a Master’s Degree and very significant prior experience can be considered
  • Fifteen+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred
  • Five+ years of experience leading a statistical or biometrics function
  • Demonstrated experience in early clinical development
  • Experience in oncology essential; experience in cell therapy a plus
  • Experience with regulatory agencies; prior record of regulatory approvals preferred
  • Prior people management experience and experience identifying organizational needs (talent, process, technology) is required

Skills:

  • Intellectual curiosity and dedication to science, innovation, and complex problem-solving
  • Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization
  • Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
  • Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Adicet
  • Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
  • Excellent written communication skills, including competent grammatical/technical writing ability
  • Excellent oral/interpersonal communication skills, including public speaking/presenting ability
  • Advanced proficiency using statistical computing platforms in the pharmaceutical area
  • Strong working knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (e.g., CDISC/ADaM)
  • Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports
  • Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.

Benefits:

  • Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

To Apply:

Please visit this webpage and search for "Head of Biometrics" to apply for the position: https://www.adicetbio.com/careers/openings/

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.