Vice President, Biometrics

Clinical Development United States


Description

Why Work for Us? 

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care 

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs. 

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. 

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. 

Zymeworks is seeking a highly motivated Vice President, Biometrics who is looking to grow their career with our company. The Vice President, Biometrics is responsible for creating and implementing the strategic direction for biostatistics, statistical programming, and clinical data management activities across all projects, in all phases of development and ensuring that proper statistical analyses and interpretations are carried out. This individual is responsible for developing functional infrastructure and in building the biometrics capabilities at Zymeworks, in collaboration with the Senior Vice President, Clinical Research, sets or significantly influences the long-term strategic direction for Biometrics in-line with the broader Development strategy.  

This position will report to the Chief Medical Officer and will be located in either Seattle, WA, Vancouver, BC, or remote. 

Job Description and Responsibilities

  • Provide strategic leadership execution for biostatistics, statistical programming and clinical data management
  • Oversee and lead Biometrics input in clinical development plans, clinical protocols, regulatory documents, publications, internal and external meetings and presentations, from IND to global registrations, and beyond
  • Build, oversee and lead a high functioning Biometrics organization to accomplish these goals
  • Contribute to overall Development Strategy, direction and organization at Zymeworks
  • 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 data management and statistical programming deliverables, including derived data definition, analysis files structure, analysis methodologies, and analysis results
  • Develop and nurture key working relationships with internal partners as well as external investigators, research organizations, and thought leaders
  • Establishes best practices, identifies the need and drives the creation of functional standard operating procedures
  • Identify innovative approaches to consider for the development of existing and future Zymeworks programs
  • Develop and plan innovative strategies for life cycle product management

Qualifications

  • A Ph.D. in Biostatistics or Statistics
  • A minimum of 15 years of pharmaceutical industry experience
  • A minimum of 5 years of experience leading a statistical or biometrics function
  • 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 accountability and cross-functional teamwork
  • Experience leading and developing a high-performing team, with ability to mentor and inspire team members at all levels
  • Ability to employ expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives
  • Entrepreneurial, self-starter with strong interpersonal and analytical skills
  • Excellent presentation skills
  • An equivalent combination of education and experience may be considered.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion. 

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract. 

 

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