Head of Biometrics

Position Details

  • Job Title: Head of Biometrics
  • Location: New York, NY (or East Coast Remote)
  • Job Category: Clinical

JOB SUMMARY

We are seeking a highly creative and collaborative Biometrics leader with significant experience in drug development to work as a member of an integrated team translating a novel platform for the discovery of new drug targets to transformational therapeutics. In this newly created position, the successful applicant will report to the Chief Medical Officer and have the opportunity to build and lead the Biometrics function at Kallyope, impacting both the strategy and execution of multiple clinical programs in a growing pipeline driven by our cutting-edge biology on the gut and gut-brain axis. As the first internal person in this function, this will be a hands-on role partnering with external consultants and managing vendors. Kallyope is based in New York City, but the right person for this role can be located anywhere on the East Coast.

KEY RESPONSIBILITIES 

  • Oversee all biostatistics and statistical programming includingstrategy program support, personnel oversight, best practices, compliance, timely study deliverables for Kallyope clinical development (including Phase I/I PK, PK/PD modeling, POC and pivotal trials) and R&D operation teams
  • Work as a core member of the clinical development team, contributing to the design of clinical study protocols that are clinicallysound and statistically efficient
  • Provide input to the clinical study team on the collection, interpretation and reporting of clinical data
  • Author Statistical Analysis Plans, statistical sections of study protocols and Data Monitoring Committee charters
  • Provide strategic input on key development documents, clinical study reports, IBs, INDs, NDAs, and labeling
  • Ensure the statistical analysis and the submission datasets meet global regulatory requirements
  • Serve as a strategic partner working closely with research, clinical development, and other relevant functional groups in providing statistical expertise and strategic oversight to requirements and interpretation of existing and future data
  • Establish biometrics SOPs, processes and relevant quality management system
  • Act as the subject matter expert in biometrics, advising company senior management, medical and clinical operations teams on the most up-to-date biostatistics methodology and tools in drug development
  • Represent the company as Biometrics expert in the communication with regulatory agencies and/or regulatory inspections
  • Manage biometry resource allocation, statistical timelines for program milestone (i.e Top Line Data, Tables, Listing Figures), and oversight of biometric related vendors to support company's clinical trial projects

 QUALIFICATIONS AND EDUCATION REQUIREMENTS

You must have:

  • PhD or advanced scientific/analytical degree
  • At least 10 years of experience in biometrics/biostatistics within the biotechnology or pharmaceutical industry
  • Track record of successfully working within individual protocols and across projects to design, drive and execute statistical strategy
  • Experience supporting statistical aspects of regulatory submissions (NDA, MAA)
  • Data Safety Monitoring committee oversight (charters, statistical deliverables, etc)
  • Familiar with managing biometrics vendors, statistical programmers
  • Leadership skills, ability to recruit and mentor a high performing biometrics team
  • Team player with the ability to partner cross functionally across all levels
  • Strong communication skills both verbal and written
  • Ability to present complex data to a range of technical and non-technical audiences

Additional preferred experience includes:

  • Experience working in a small or mid-sized biopharmaceutical company

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