Vice President, Biometrics

Location
92130, San Diego
Posted
Nov 02, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Come join our world-class team evaluating, in-licensing and developing innovative therapeutic products internationally.

HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. HUYA’s lead compound in oncology, HBI-8000, is in late stage clinical development in Japan and Korea as monotherapy for the treatment of hematological malignancies. In the United States, HBI-8000 is being developed in combination with immune checkpoint inhibitors in solid tumors. The Company’s lead cardiovascular program, HBI-3000, is in Phase 1 in Europe. Two additional compounds are in early evaluation for oncology and cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

This position reports to HUYA’s Global Head Clinical Operations & Program Management. Responsibilities include directing clinical trial biostatistics and programming activities for Clinical; works on abstract problems across functional areas of the business. He or she will contribute to, and support, corporate goals to progress the company’s portfolio of products across therapeutic areas.

This is an office-based position that works in a cross-functional and dynamic environment.  Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.

Primary Duties and Responsibilities

  • Partner with research and development teams, providing strategic input on design options for future studies and development plans
  • Build cross-functional relationships with medical affairs, clinical operations, regulatory affairs, and as a partner to other product team leaders
  • Collaborate with clinical operations to lead CRO and vendor interactions for biometrics functions, including data management, statistical and programming activities.  Take appropriate action in all dealings with CRO partners to ensure that best practices are followed
  • In collaboration with clinical and medical teams, interpret trial data and recommend most informative and insightful data display
  • If needed, perform statistical programming utilizing SAS.  Oversees programming work performed by staff or vendors
  • Ensure all statistical deliverables are met for CRFs, SAPs, CSRs, ISE / ISS documents, publications, and presentations
  • Oversee all clinical trial database deliverables, including but not limited to: finalized clinical study database validation plans, electronic data transfer protocols and proper data transfers with 3rd party vendors, data cleaning and lock activities
  • Oversee implementation and management of SAS software
  • Respond to regulator’s inquiries for products undergoing registration and approved products
  • Internal and external team partnerships to compile and maintain master SAS data repository
  • Develop and maintain biometrics SOPs and all associated training materials
  • Collaborate with clinical operations to develop metrics and ensure the organization meets or exceeds these metrics
  • Represents and communicates biometrics output information effectively across all levels of the organization
  • May be responsible for direct supervision or line management
  • Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals.
  • Perform other duties as required.

Job Qualifications and Requirements

  • Strong background and working knowledge of statistical methods that applies to all phases of clinical trials
  • Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices
  • Must have a working knowledge of all appropriate relevant regulatory guidance (e.g. ICH, FDA and EMEA)
  • Direct submission/filing experience is preferred. Submission experience outside of the US is an asset
  • Proficiency in SAS and nQuery software packages. Knowledge of CDISC requirements
  • Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
  • Travel 10% of time on average in accordance with company and/or project requirements.
  • Computer skill should include proficiency with Microsoft Office suite of software
  • Excellent oral and written communication skills
  • Fluency in written and verbal English
  • International experience is a plus

Education and Experience

  • MS or Ph.D. in Statistics/Biostatistics or closely related field (oncology experience preferred)
  • Minimum 10 years’ industry experience in clinical/medical research, but generally has 12+ years of highly relevant experience
  • Minimum 5 years in a management role within Biometrics

The position is full‐time and the candidate must be within commuting distance to HUYA’s Del Mar, CA headquarters.