|Job title :||Vice President Biometrics|
|Job type :||Permanent|
|Contact name :||Yanick Millet|
|Contact number :||+44 (0) 207 255 6610|
|Contact email :||email@example.com|
As the Vice President of Biometrics you will guide development teams in the successful design of global clinical studies, and the lead the collection, analysis and interpretation of data to enable our early- and late-stage pipeline molecules.
Additionally, the VP will be responsible for building, overseeing and leading a Biometrics organization to accomplish these goals, as well as a contributing to overall Development Strategy, direction and organization.
- Provide operational leadership to the Clinical Development projects portfolio,
- Provide high quality management, functional expertise and coaching to ensure that the Data Managers and Statisticians can maximally contribute to the delivery of Clinical Development objectives and strategy,
- Develop and maintain effective working relationships with company functions including Medical, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Training & Compliance departments,
- Provide leadership and guide Biometrics strategy and goals in accordance,
- Provide statistical and methodological support to interactions with regulatory agencies (including scientific advice, oral explanations, response to questions of agencies, preparation of briefing books and the preparation of New Drug Application/Marketing Authorization Application dossiers),
- Define and implement the strategy for data collection, data cleaning and statistical analysis applied to clinical projects and in compliance with regulatory requirements,
- Ensure appropriate resource management to ensure sufficient, appropriately qualified and trained resources (including utilization of external consultants, where appropriate) are identified and allocated to the Data Management, SAS programming and Statistical Analysis activities to support clinical projects,
- Manage members of the Biometrics team, including biostatisticians and data managers, including Performance Management and career development,
- Maintain oversight and assume responsibility for budget, quality (according to Standard Operating Procedures - SOP), planning and reporting,
- Ensure development and communication of best practices for the team,
- Develop and implement standardization of processes in alignment with the SOPs and the international regulations,
- Assign Statisticians and Data Managers to clinical projects and manage human resources in accordance with the needs of clinical projects,
- Maintain an overview of execution and delivery of Data Management, SAS programming and Statistical activities in accordance with the business objectives,
- Contribute to authorship and review of protocols, abstracts, scientific publications and communications and clinical study reports.
- Master's Degree or equivalent in Biostatistics or related discipline (PhD preferred) and - Proven, significant Clinical Research/Development or related industry experience in Biometrics (as Data manager and/or Statistician) including implementation of risk management of budgets and resourcing plans,
- Experience in the management of a team and working in a cross-functional setting,
- Experience in influencing and negotiating at all levels,
- Ability to improve processes and in actively supporting the implementation of new processes,
- Successfully worked in an international environment, involving prioritizing and managing multiple tasks simultaneously.
- Complete knowledge of ICH/GCP, SOPs / Guidelines (including regulatory requirements related to Statistics) and quality standards,
- Detailed knowledge of all operational aspects of Biometrics (Data Management, Statistical Programming, Statistical analysis),
- Ability to communicate clearly and accurately in both written and spoken English,
- General computer skills and broad knowledge of statistical packages.
- Decision Making - Ability to make sound, timely, decisions within areas of own responsibility, recognize when and how other stakeholders need to be involved, and commitment,
- Collaboration and Teamwork - Successful and comfortable working in a complex multi-functional matrix through all stages of clinical projects.
- Project Management - Successful track record of managing high-performing teams is preferred. Experience in influencing and negotiating to achieve team delivery.
- Communication - Good written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organization.
- Personal Organization - Self-motivated and achievement driven, highly organized, excellent ability to prioritize own tasks and to optimize team performance.
- Cost and financial awareness - Good judgment in relation to tradeoffs between cost and effectiveness