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

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com

Job Summary

The VP Biometrics is responsible for directing clinical trial biostatistics and programming activities for the Clinical Group. Works on abstract problems across functional areas of the business. Contributes to, and supports, corporate goals to progress the company’s portfolio of products across therapeutic areas. Responsible for recruiting, resourcing, and building infrastructure for Biometrics in support of HUYABIO’s portfolio. This position reports to the Chief Medical Officer.

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

•Analyzes data and methodology to be used in clinical studies undertaken by HUYABIO.

•Collaborate with clinical operations to lead contract research organization (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.

Job Description

• 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.

Skills and Competencies

• Thorough knowledge of clinical trial designs and relevant epidemiological designs.

• Real world study designs, creative analyses of real-world data, meta-analyses using published medical literature.

• 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

• Ability to effectively manage multiple priorities in a fast-paced environment to meet tight deadlines.

• 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 HUYABIO’s Del Mar, CA headquarters.

To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity

employer.

HUYABIO International

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