This person will be 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. Assists the VP in recruiting, resourcing, and building infrastructure for Biometrics in support of HUYABIO’s portfolio.
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
- Works under the supervision and direction of the VP, Biometrics
- 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 leading 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.
- Assists in the implementation and management of SAS software.
- Provide information to regulator’s inquiries for products undergoing registration and approved products.
- Internal and external team partnerships to compile and maintain a master SAS data repository.
- Assist in developing and maintaining 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.
This position is not a GxP covered position, but may on occasion perform some covered GxP activities in connection with the Company’s development projects. You are required to read and understand the Company’s standing SOPs as amended or revised and be up to date on any GxP or Company training assigned to you.