Passion for Innovation. Compassion for Patients.™ Daiichi Sankyo is one of the world's 20 leading pharmaceutical companies and employs almost 32,000 people. The company's world headquarters are in Tokyo. Its European base is located in Munich, Germany. Daiichi Sankyo Europe has affiliates in 12 countries. For our European headquarters in Munich we are seeking highly qualified candidates to fill the position: Director Biostatistics (m/f) The Position: As a globally recognised innovator enable ‘Good Medicine Development’ in EU. Collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR for simple and complicated trial designs and challenging analyses. Day-to-day operational managerial role of single EU Biostatistics team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions across all therapeutic areas (oncology, cardiovascular, metabolic and frontier). Through strategic leadership in project teams add value to Daiichi Sankyo by accelerating worldwide product approvals and enhancing EU product market share and appeal. Enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure (systems, tools, processes, SOPs, metrics, competencies). Represent EU-BDO on GBDMC. Responsibilities: Leads a regional Biostatistics group who oversees all project related biostatistical activities at Daiichi-Sankyo. Develops, directs, prioritises and monitors all statistical programs and processes relevant to clinical trial design, data collection and input, data analysis, data display, QC, and reporting of results with the primary purpose of accelerating worldwide product submissions and investigational product approvals. Oversees and monitors project timelines to ensure established corporate target dates are met. Encourages, monitors, and facilitates biostatistical activities and interactions between Daiichi-Sankyo – Gerrards Cross, Daiichi-Sankyo India and Daiichi-Sankyo Munich toward the development and implementation of global statistical analysis and reporting standards. Review of all clinical trial protocols, clinical trial reports, and analysis deliverables. Ensures quality of all deliverables related to data analysis, display, and reporting of clinical trial results. Provides close interaction with cross-functional groups in the review and selection of CROs; develops and reviews CRO contracts; tracks CRO milestone, timelines, and issues; resolves same. Develops long-range plans for the future of Biostatistics within Daiichi-Sankyo, and monitors metrics and evaluates staff performance. Manages and develops the technical competence and careers of the biostatistical staff. Provides leadership to Biostatistics in setting short-term and long-term departmental, project, and professional goals and objectives. Creates momentum, energy, and opportunities for visibility of group within corporate and functional settings. Expands support to new areas and builds new cross-functional relationships while solidifying and enhancing existing relationships. Acts as the “champion” for Daiichi Sankyo Biostatistics in all corporate and industry forums, and appropriately communicates plan and vision to Management. Professional and personal skills: Ph.D. in Statistics, Biostatistics or Mathematics 10+ years Pharmaceutical Industry experience. 6+ years supervisory/management and project management experience. Exposure to vendor risk and performance management, compliance and oversight. Good oral and written communication skills Proficient in Microsoft Office Suite including Word, Excel, and Project Demonstrated problem solving, analytical, organization, and time management skills Excellent managerial skills; coaches, guides, and professionally develops direct reports Exhibits customer focus, flexibility, and team spirit Ability to lead and influence others Demonstrated experience in leading remote teams Ability to function effectively in different cultural settings Experience in the implementation of electronic data capture (EDC) What we offer: We offer an interesting, diversified and challenging position, good contractual conditions, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth. Are you interested in this opportunity? Then we look forward to your online application.
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