Vice President, Biometrics

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

Zogenix is seeking a Vice President of Biometrics to build and oversee the Biometrics organization with accountability for study designs, data analysis and interpretation of results in collaboration with partner functions in Development and Medical Affairs. The VP provides input into Zogenix’s drug development strategy and assists with regulatory interactions. Acting as a senior member of the Development Leadership Team, the VP of Biometrics will also interact with global Health Authorities, as well as our partner contract research organizations (CRO). The VP of Biometrics will provide biometrics consultations to Business Development, Commercial and Research organizations as needed. The VP is responsible for recruiting, resourcing and building infrastructure for Biometrics to support the Zogenix portfolio. This position reports to the Chief Development Officer.

The ideal candidate has a demonstrated expertise in Rare Disease global clinical development and a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.

Responsibilities

  • Ensure overall effective operations in biostatistics, clinical data management, and clinical/statistical programming
  • Oversee and lead Biometrics input in clinical development plans, clinical protocols, regulatory documents, publications, internal and external meetings and presentations
  • Accountability for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols, and assures statistical integrity, adequacy and accuracy
  • Accountability for the consistency and accuracy of CRO data management and statistical programming deliverables, including derived data definition, analysis files structure, analysis methodologies, and analysis results
  • Represent Zogenix Biometrics in Health Authority interactions as needed
  • Develop and nurture key working relationships with internal partners as well as external investigators, research organizations, and thought leaders
  • Continue to build and resource the Biometrics team, mentors and develops members of the Biometrics organization
  • Establish best practices, identify the need and drive the creation of functional standard operating procedures for clinical data management, biostatistics, and statistical programming
  • Other duties as assigned.

Qualifications

  • Ph.D. in Biostatistics or Statistics
  • At least 15+ years’ industry experience, including line management for at least 7 years; overseeing multiple molecules in development
  • Good Clinical Practice (GCP) proficient
  • Broad and extensive knowledge of theoretical and applied statistics
  • Demonstrated understanding of Phase I – Phase IV drug development
  • Comprehensive understanding of regulatory guidelines for drug development
  • Expert in the principles and techniques of data analysis, interpretation and clinical relevance
  • Expert level of proficiency with SAS and/or other statistical software packages
  • Proven track record of fostering creativity, productivity, execution with a sense of urgency, teamwork, accountability, and cross-functional collaboration
  • Entrepreneurial, self-starter with strong interpersonal and analytical skills, high ethical standards and proven ability to work effectively with cross-functional partners and other internal stakeholders 
  • Excellent external networking, relationship and presentation skills and a strong presence
  • Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives

Fit with Zogenix culture

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with Zogenix’s Core Values
  • Excitement about the vision and mission of Zogenix
  • Flexibility
  • Integrity

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