Vice President, Biometrics Lead

6 days ago

San Diego, California, United States Avidity NanoMedicines Full time
Job Title: Vice President, Biometrics

At Avidity Biosciences, we are seeking a highly skilled and experienced Vice President, Biometrics to lead our biostatistics and programming team. This is a key role that will be responsible for biometric output delivery across our clinical programs, as well as deciding on policies, data standards and standard procedures for the department.

Key Responsibilities:
  • Lead the biostatistics and programming team and set the strategy and resourcing for the department
  • Accountable for statistical design proposals, study-level and integrated analysis for clinical programs
  • Lead statistical expert for interaction with regulatory authorities and external scientific communication
  • Accountable for high quality, impactful and timely biometric outputs
  • Recruit, evaluate and manage team members and instill company values
  • Technically guide junior staff
  • Ensure effective collaboration and goal setting with colleagues in clinical development, data management, development sciences, medical affairs and other departments
  • Oversee statistical analysis and data presentation sections of regulatory documents and license applications
  • Ensure best practices to improve quality, efficiency and effectiveness in the department
  • Ensure compliance with CDISC standards for eCTD submission
Requirements:
  • Masters/doctorate in Statistics
  • At least 15 years of biostatistics in the pharmaceutical/biotechnology industry, with line management experience
  • Strategic thinker who will guide not only innovative endpoint evaluation strategies for the clinical trials but also the evolution of the department within a growing and multinational commercial organization
  • Clear, effective communicator who explains biostatistics principles and makes strategic recommendations in an audience-appropriate way
  • Demonstrable leadership experience with drug/biologic license applications with a track record of solving problems and effectively responding to regulatory questions
  • Fluent in handling of imputation methods, measurements of secular change, longitudinal data integration and mixed models for repeated measures
  • Extensive knowledge of the latest programming standards and data infrastructure
  • An accountable player-manager who can balance leadership and resource organization with delivery to program goals
  • Awareness of Artificial Intelligence initiatives in biometrics
  • An innovator who can present the range of efficacy, PRO and safety data persuasively
  • Experience with rare diseases is required
  • Experience with management of CROs/biostatistics vendors is required
What We Offer:
  • The base salary range for this role is $315,000 - $352,000
  • The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors
  • This role can be located remotely, though travel to company and meetings will be required
  • Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match
  • In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off
  • A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program

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