Title:  China External Innovation Lead

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We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• This position is onsite in CITY, STATE or CITY, COUNTRY    
• This position is hybrid and will require you to be onsite X days per week/month/quarter
• This position is a field-based opportunity in CITY, STATE
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Working Hours

40

Purpose and Scope

As a very senior statistician, the primary purpose of the Statistical Science Lead and Clinical Biometrics Site Head, China is to provide regional strategic statistical leadership across projects and have a major influence on the technical capabilities of the department. With an exceptional knowledge of the scientific area of responsibility, the position is expected to ask critical scientific questions and critique devised hypotheses, designs and results interpretation 

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​The position will support Senior management with decision making at the asset and portfolio level, identifying gaps in knowledge, tools and internal skills, or contributing to Shared Goals (SG) and long-term strategic plans. The position receives for resolution unique, far-reaching, and previously unresolved problems. 

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​The position works independently and involves the right level of participants as needed (cross functional peers and Sr management) within or outside R&D. The position represents Astellas in interfaces with the regional regulatory agency, chair sessions in international statistics meetings, participate in industry-wide technical discussions and represent Astellas in professional societies.

Role and Responsibilities

The position directs Astellas statistical strategy, creates and organizes new areas of methodological research and is accountable to provide best in class data science support to Astellas drug development programs. 

• ​Advises project teams and statistical leads on challenging statistical design, analysis and decision-making issues.  

• ​Performs/supervises modeling and simulations, leverages external experts to provide input to clinical development issues. 

• ​Provides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts 

• ​Reviews key project level documents  

• ​Participates in due diligence activities, reviews data and advises company 

• ​Presents and defends complex statistical solutions to internal governance committees, key stakeholders, or regulatory bodies in a compelling and impactful way 

• ​Develops and implements best in class standards, processes, and SOPs in statistics 

Continue:Role and Responsibilities

Personal development / Collaboration 

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• ​Coaches and supports statistical leads in providing best in class data science support to Astellas drug development programs. 
• ​As a leader of external industry or professional organizations, the position develops and maintains relationships with leading academic institutions and key statistical opinion leaders and actively participates in professional association activities to support the branding of Astellas  
• ​Demonstrates an in-depth understanding of Astellas’ priorities, and uses the position to advance Astellas’ mission through high quality statistical work 
• ​Is exceptionally effective in ensuring that Astellas stays at the forefront of recruitment, training, professional development and retention of statistical personnel. 
• Serves as a functional site head for Clinical Biometrics and coordinate local activities.

Essential Qualifications

• PhD or M.S in Biostatistics, Statistics or related scientific field 
• ​12+ years (15+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas 
• ​Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data 
• ​Knowledge and skills in SAS required, knowledge of R preferred. 
• ​Experience working in an international environment and in a matrix environment. 
• ​Broad experience in multiple indications, has supported multiple global submission and drug development programs at different stages. 
• ​Record of publications in clinical trials or methodological research in highly regarded peer review journals, or invited speaking engagements, 
• ​Understand Real World Evidence, omics, digital endpoints and Machine Learning.

Preferred Qualifications

Benefits

Careers | Astellas

Salary Range

Why Astellas

• We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. 
• People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Learn more at Astellas.com

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Skills and Capabilities