The Senior Manager Biostatistics will be responsible for leading biostatistics strategy and activities for a compound and/or for individual clinical studies. This will include study level statistical deliverables such as study design, protocol developments, SAP, statistical analyses and study reports and responsibility for CRO management and oversight. The position holder will be responsible to ensure statistical leadership during interactions with internal and external stakeholders (key opinion leaders, regulatory and pricing agencies) and in addition may coordinate other statisticians assigned to the same project. Support of publication activities as well as value dossiers preparation (e.g. AMNOG, NICE, etc.) is although the responsibility, to maximize the success for the Daiichi Sankyo portfolio in terms of Market Access.

Roles and Responsibilities:

Responsible for all assigned project and protocol level statistical deliverables and supports publication in projects

• Protocol design, SAP, statistical analysis, reporting, publication, CRO
• Coordination and oversight in close collaboration with project team(s) and Steering Committees
• Ensures timely and accurate completion of bio statistical deliverables
• (internal tasks or tasks of CROs)
• Ensures implementation of high quality, state of the art statistical methodology,
• efficient working processes

Support the development, execution and implementation of the European HEOR strategy

• Planning, set-up and execution (by job holder or CRO) of additional statistical analyses as needed and requested by HEOR colleagues for national value dossiers
• Review of value dossiers to ensure proper description of statistical components of the dossier
• Participation in meetings with HEOR/HTA authorities

Broaden knowledge of statistical methodology in oncology and value dossiers

• Continued effort to enhance and share experience and methodological knowledge internally with bio stats colleagues and other departments

Support other departments (Medical Affairs, Marketing, RWE & Clinical studies) in maximizing the success for the company portfolio

• Ensure proper supports in publications and congress activities based on assigned project
• Represent biostatistics internally and externally to ensure adequate implementation of statistical methodology