Principal Biostatistics

**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:
**Principal Biostatistics (M/F/x)**:
**The position**:

- The position holder will manage, with limited direction, Biostatistics study activities assigned, to support non-R&D functions, and ensure high quality deliverables are on time and within budget.
- The position holder will partner with internal and external stakeholders to optimize Statistical methods, processes and standards.
- The position holder will act as main statistical contact for the assigned study activities, in particular in cross-functional Study team(s).

**Role & 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; Coordinate the statistical programmers involved in the development and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific communications.
- Contribute to documents submitted to regulatory or pricing authorities.
- Responsible for providing direction and execute oversight of vendor delivery.
- May lead and/or participate in departemental 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.
- Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.

**Professional experience & education**:

- Master’s degree or PhD (preferable) in statistics, mathematics or related fields
- 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

**Why work with us?**: