Associate Director, Biostatistics, RWE

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

This position leads secondary data studies in the study design, statistical analysis, interpretation of results with some supervision. This position interacts with study teams to provide statistical and scientific expertise in the project deliverables. This position is also expected to provide an excellent communication with people from the different functions.

Responsibilities:

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 closely with internal/CRO statistical programmers as needed.

Real-World Evidence (RWE) Activities: Provides 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. Work effectively with the study team to support and provide the planned deliverables.

Excellent Communication:Work effectively with the customers/stakeholders and clearly communicate the statistical and scientific input in the design, conduct, analysis, and results interpretation.

RWEAnalytics: Foster new methodology and provide innovative analytics technique & method (e.g. External Control Arm, machine learning, predictive model).



Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

PhD in Statistics/Biostatistics or Pharmaco-epidemiology or Master’s in Statistics/Biostatistics or Pharmaco-epidemiology, PhD is strongly preferred.

Minimum 5 years relevant experience in the pharmaceutical industry with Ph.D. or 7 years with Masters.

Good 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.

Oncology experience preferred.