Principal Biostatistics (m/f/x)

at  Daiichi Sankyo Europe

PASSION FOR INNOVATION. COMPASSION FOR PATIENTS.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are looking in our European Headquarters in Munich or in our affiliates in Europe (remotely also possible) for a:

REQUIREMENTS

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields as well as at least 5 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
• Strong knowledge of major statistical methods within industry standards
• Proficiency on handling CDISC standards and statistical software such as but not limited to SAS and R
• Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
• Demonstrated expertise in study design, conduct and execution
• Excellent English language skills
• Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
• Demonstrated entrepreneurship and leadership and proactive problem solving
• Ability and interest to work remotely with worldwide team members across cultures

PURPOSE OF THE FUNCTION

The Principal Biostatistics will manage, with limited 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 reporting (CSR)
• 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.
• May participate as subject matter expert in meeting or teleconferences with health authorities.
• Responsible for providing direction and execute oversight of vendor delivery
• May lead and/or 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.
• May act as subject matter expert for statistics representing EG department in cross-functional teams.
• Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.