Director Biostatistics RWE EU

Daiichi Sankyo Europe

Munich, Germany

The position:

This position leads the RWE activities in Europe (EU) by collaborating with the global counterparts, mostly in US. When needed, this position leads the secondary data studies in the study design, statistical analysis, interpretation of results independently with minimal supervision. This position interacts with collaborators to provide a strong statistical and scientific expertise in the project planning and deliverables. This position is also expected to provide an excellent communication to provide an input in the use of real-world evidence (RWE) in the entire value chain.

Roles & responsibilities:

EU RWE Activities: Network with the EU internal and external experts in RWE to engage in the latest RWE initiatives/activities in EU. Integrate EU RWE initiatives/activities in the global strategy with some supervision. When needed, provide guidance in scientific and statistical aspects of RWE activities and support deliverables to ensure the quality. RWE activities include the real-world data (RWD) inquires, RWD/E consultation, and the feasibility assessment using the secondary data.
Secondary Data Study Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and study report: Leads statistical activities for studies including study design, protocol development, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and study report input and review. Acts as main statistical contact for the assigned studies and projects. Work effectively with the study team to support and provide the planned deliverables. Work closely with internal/CRO statistical programmers as needed.
RWE Department Strategy: Provides input to build a strong RWE department in developing statistical expertise, promoting innovations, maintaining operational excellence and building efficient processes and standards for RWE.
Excellent Communication: Work effectively with the customers/stakeholders and clearly communicate the statistical and scientific input in the design, conduct, analysis, and results interpretation.
RWE Analytics: Foster new methodology and provide innovative analytics technique & method (e.g. External Control Arm, machine learning, predictive model).

Professional experience & education:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
PhD in Statistics/Biostatistics or Pharmaco-epidemiology.
Minimum 7 years relevant experience in the pharmaceutical industry.
Excellent understanding of statistical methodologies, real-world data, and observational studies.
Experience on statistical software (e.g. SAS, R, Python) and secondary data sources including registries, EMR and claims is an advantage.
Excellent oral and written communication skills.
Excellent Project planning skills.
Excellent collaborating skills.
Oncology experience preferred.

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