Passion for Innovation. Compassion for Patients.
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu .
For our headquarter in Munich we are seeking highly qualified candidates to fill the position:
Manager Biostatistics (m/f/x) Purpose of the function
The Manager Biostatistics will manage, with direction, Biostatistics study activities assigned, to support non RD functions, and ensure high quality deliverables are on time and within budget. Furthermore the position holder will partner with internal and external stakeholders to optimize statistical methods, processes and standards as well as act as main statistical contact for the assigned studies, in particular in cross-functional study teams. The position will either be based in one of our offices in Europe or from home within one of these countries.
Responsibilities
- Responsible for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on Clinical Study Report
- Support Medical Affairs and HEOR/HTA strategies: Set-up additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and health economic endpoints; Review or co-author the value dossier and scientific communications
- Contribute to documents submitted to regulatory or pricing authorities
- Responsible for routine oversight of vendor delivery
- Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
- Maintains current knowledge of industry best practice in statistical methodology
Requirements
- Master’s degree or PhD (preferable) in statistics, mathematics or related fields as well as at least 2 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting.
- Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
- Knowledge of statistical methods related to clinical studies and/or to HEOR/HTA applications
- Solid knowledge of statistical software such as but not limited to SAS and/or R, with hands-on programming experience, and good knowledge of CDISC standards
- Excellent English language skills
- Good communication skills, both oral and written, in explaining in simple terms complex concepts
- Ability and interest to work remotely with worldwide team members across cultures
What we offer
Working at Daiichi Sankyo
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
