Head of Biometrics

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Head of Biometrics

The Head of Biometrics will be accountable for driving and supervising the company's biometrics activities for all projects from the IND-enabling stage through to the post-launch period. This includes supervision of all biostatistical and statistical programming activities. This role will require direct hands-on contributions, as well as oversight of both internal and external biometrics staff.

Cambridge
Nov 1 2021
Responsibilities
  • Guide clinical study design and supports data analysis and interpretation.
  • Optimize the development of a precision medicine approach, using well-established biostatistical principles, but also being willing to offer creative solutions for ex vivo lentiviral gene therapy in the treatment of lysosomal storage diseases.
  • Establish biometrics SOPs, processes, and relevant quality management system in collaboration with Quality Assurance.
  • Lead biometrics efforts and cross-functional initiatives and provide guidance and recommendations to key stakeholders within the organization
  • Support the project team with innovative approaches to resolve complex strategic issues in protocol design and data analysis.
  • Lead a highly functional biometrics department to support other Clinical Development functional teams.
  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for drug and diagnostic products.
  • Remain current with biometrics standards and ensures submissions are aligned with current standards/guidance.
  • Act as the subject matter expert in biometry, advising company senior management, medical and clinical operations teams on the most up-to-date biostatistics methodology and tools in drug development.
  • Work as a core member in clinical development team, contribute to design a clinical study protocol that is clinically sound and statistically efficient.
  • Represent the company as Biometry expert in the communication with regulatory agencies.
  • ·Manage biometry resource allocation to support company’s clinical trial projects and recruit appropriate talents
  • if needed.
  • Monitors compliance with biometry requirements and commitments.
  • Holds themselves and their teams to the highest levels of integrity, in line with company values
  • Collaborates well with peers and mentors the junior staff.
Minimum Requirements/ Qualifications
  • 15+ years’ experience in clinical trial biostatistics and statistical programming. Experience in one or more small or mid-sized biopharmaceutical company is strongly preferred.
  • Track record of successfully working within individual protocols and across projects to design, drive and execute clinical pharmacology and biostatistical strategy.
  • Ability to manage self, lead and manage others in the successful and timely completion of all biometrics activities for a study or multiple studies from end to end.
  • Excellent oral and written English communication skills.
  • Excellent communication, analytical and organizational skills.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Experience working effectively in a globally dispersed, virtual and hybrid team environment with cross-cultural partners.
  • Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
  • Strong interpersonal skills and ability to thrive in a matrix environment
  • Experience in managing external collaborations, contract laboratories and timelines and budgets.
  • Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation.
  • Flexibility to work on multiple projects as the portfolio evolves over time.
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer