Title:  Real World Data Scientist

Location

Position：Real World Data Scientist

Grade: GG18

Report to: Head, RWDS B&O

Location: Beijing/Shanghai, China

Purpose and Scope

As a Director of RWDS, you will be an analytic researcher informing and conducting RWD studies at any time in the drug lifecycle. You will work across the product lifecycle to inform strategy and design of observational studies, primarily focused on local China needs whilst also taking some global responsibilities. 

You will work directly within the RWDS team to design and execute observational studies and RWD analyses for internal and external consumption and partner closely with Clinical Development & Operations, Medical Affairs, and Pharmacovigilance/ Pharmacoepidemiology colleagues in their research. Additionally, you will collaborate closely with others in RWDS, EGAA, Biometrics and the broader Quantitative Sciences & Evidence Generation department to enhance our offerings.

RWDS is multidisciplinary and provides RWE strategic input, study design, statistical and programming support to projects. Team members apply their unique knowledge, skills and experience in teams to deliver decision-shaping real-world evidence.

Responsibilities and Accountabilities:

•    Identify opportunities to add value to Astellas drug development programs & marketed products through use of RWD, and provide best-in-class data science support to the China organization assigned programs in relation to RWD
•    Design observational studies (primary and/or secondary data) 
•    Execute observational studies and RWD analyses using real world databases or oversee vendors or other RWDS staff in executing observational studies 
•    Write, review, or contribute to key study documents to ensure optimal methodological & statistical presentation. These documents include, protocols, analysis plans, tables and figure (TLF) specifications, study reports, publications
•    Ensure efficient planning, execution and reporting of analyses 
•    Advise as subject matter expert in specific data access partnerships. 
•    Represent the company on matters related to RWD analysis at meetings with regulatory authorities, key opinion leaders and similar experts/bodies as needed. 
•    Contributes to vendor selection with partner functions.
•    Lead the creation and upkeep of best practices, tools/macros, and standards related to methods, data and data analysis at Astellas. 
•    Collaborate with RWDS, EGAA and Biometrics colleagues and cross-functional teams in Development, Medical Affairs and Pharmacovigilance.
•    Mentor and guide junior members of the RWDS team.

Required Qualifications:

A doctorate or master's degree in statistics, data science, pharmacoepidemiology or similar discipline. 
•    More than 8 years of pharmaceutical industry hands-on experience in design and execution of observational studies and analyzing RWD. 
•    Abreast of real-world data capabilities, data sources and evidence opportunities in China - with extensive experience of generating RWE in the Chinese setting.  
•    Good understanding of entire drug development process with ability to see the “big picture”  
•    Experience in analyzing a diverse set of RWD study types (description, association, prediction, causation), including incidence & prevalence, treatment patterns, healthcare resource utilization, cost, outcomes, safety and effectiveness. 
•    Advanced and broad knowledge of statistical methods, along with understanding of industry practices & guidelines related to the analysis of RWD.
•    Working knowledge of SAS and R required, Python or SQL beneficial.
•    Well-versed in data visualization, statistical analysis, and preferably machine learning methodologies. 
•    Advanced knowledge in non-interventional research design for primary data collection (i.e., prospective) as well as secondary use of data studies. 
•    Commitment to seeking innovative methodology to generate data-driven insights. 
•    Experience working across geographies with globally distributed teams.
•    Self-starting performer with a strategic mindset and the demonstrated capacity to operate both independently and collaboratively in a fast-paced, team-oriented setting. 
•    Excellent communication, collaboration and influencing skills, and experience working in cross-functional teams.
•    Strong written and verbal English communication skills; Chinese language proficiency as required by local role expectations. 

Preferred Qualifications

•    Experience with observational studies utilizing major EHR and claims databases from other countries in APAC, US, UK and/or EU
•    History of establishing external collaborations with organizations in the RWE ecosystem
•    Experience representing statistical or RWD functions in discussions with regulatory authorities or HTA bodies
•    Track record of scientific publications or congress presentations