What are the responsibilities and job description for the Director, Biostatistics-RWE position at Daiichi Sankyo?
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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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.
Summary :
This position leads the RWE activities in the clinical development area by collaborating with the counterparts in R&D. 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 from the strategic mindset 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) from the broader view in the entire value chain.
Responsibilities :
RWE Activities in Clinical Development : Network with the clinical development counterparts to understand the holistic clinical development plan, identify the opportunities to use RWE to accelerate the drug development, and integrate the RWE in the clinical development plan. RWE activities include the real-world data (RWD) inquires, RWD / E consultation, and the feasibility assessment using the secondary data. Provide insight from RWE to guide the clinical team to make the informed decision. Guide and coach the junior members of the team to think holistically about the use of RWE.
Secondary Data Study Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and study report : When the secondary study is needed, leads or guide the team members on the statistical activities for studies including study design, protocol development, SAP development, statistical analysis, 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.
Data Statistical Science RWE Strategy : Provides input to build a strong RWE group in developing a strategy to use RWE at enterprise level as well as in enhancing the statistical and RWE expertise, promoting innovations, maintaining operational excellence. Provides input to build 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. Clearly communicate with direct report or team member on the assignment, purpose, and priority.
RWE Analytics : 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 :
Master's Degree in Statistics / Biostatics required.
PhD in Statistics / Biostatistics or Pharmaco-epidemiology preferred.
Experience :
10 Years of relevant experience in the pharmaceutical industry with a masters degree required.
Minimum 7 years relevant experience in the pharmaceutical industry with a PhD preferred.
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.
Daiichi Sankyo, Inc. is an equal opportunity / affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
