Algemene informatie

Job Advert Title
Executive Director - Medical & Development Real World Analytics
Locatie
Nederland, Verenigd Koninkrijk
Function/Business Area
Medical & Clinical, Research
Afdeling
Biostatistics
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

About Astellas:


At Astellas we offer an inspiring place to work and a chance to make your mark in doing good for others.


Our expertise, science and technology make us a pharma company, our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.


Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.


Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword, it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.


Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


This position reports to the VP of Biostats and Statistical Programming and will provide vision, leadership, and strategic direction globally for Medical & Development Real World Analytics (M&D RWA). Working alongside our Biostatistics groups, the role will support the HEOR function and interface with various teams to develop appropriate Real World Evidence (RWE) generation approaches to meet the evidentiary needs of Astellas.  


In addition this role is accountable for all analytical needs (data/statistical analysis, data mining and AI) and state-of-the-art methodologies related to the generation of RWE across our global regions. Generated RWE will be used internally and externally to support clinical trial design, regulatory approval, launch, market access and pricing, and other identified needs.


The overall objective for this function (which will also be part of this role) is to centralize RWE into one unit to support compounds/indications and Therapy areas and capability-building/training. This will ensure Astellas is optimizing its pipeline and product potential through the innovative collection and/or use of Real World Data


Key Responsibilities are noted below:


  • Drive the M&D RWA vision and serve as point of contact across the business
  • Ensure scientific rigor and compliance with relevant guidelines when designing non-interventional studies and serve as methodology expert for RWE data analyses across various data types and applications
  • Identify trends, emerging patterns and stakeholder expectations in the application of RWE to support regulatory approvals, HTA assessments and payer requirements
  • Promote and implement innovative methods, technologies, collaborations and tools to maximize the value of RWD
  • Oversee the translation of research questions into well designed RWE studies, innovative and methodologically robust analysis plans, and compelling analysis/interpretation in close collaboration with key global and regional M&D functions and interfacing teams.
  • Build a rapid response team able to manage ad hoc requests with speed, flexibility and quality.
  • Develop and maintain efficient and fit-for-purpose RWE generation processes, SOPs and tools, in compliance with applicable guidelines.
  • Participate in the development and presentation of training on RWE-related topics
  • Collaborate across the organisation and form effective partnerships with cross regional  groups such as Medical Affairs, Biostatistics, Clinical Science, PV, HEOR and Market Access to support the development and execution of RWE strategies and tactics
  • Hire, retain and develop a global team of industry leading RWD professionals
  • Manage and oversee outsourcing, vendor and partnership management activities to drive delivery to key milestones


Essential Knowledge & Experience:


  • Significant experience from within the pharmaceutical industry/biotech or CRO environment and specifically in human drug development
  • Evidence of solid leadership experience from within pharmaceutical development, HEOR, analytics or product strategy with line management responsibilities
  • Expertise in the statistical analysis of RWD such as claims data, registries and electronic healthcare as well as visualization of healthcare data
  • Advanced knowledge of epidemiologic methods and/or outcomes research and the application of retrospective and prospective observational studies to generate RWE
  • Solid understanding of drug development processes and strategies and of compliance, privacy, regulatory and safety pertinent to real-world data analytics
  • Understanding of the RWD landscape and familiar with market-specific data and evidence requirements.
  • Demonstrated ability to lead independently, translate strategic plans into goals and objectives
  • Strong influencing skills and ability to collaborate in a matrix organization
  • Able to demonstrate strategic thinking, integrity, collaboration, commitment.


Preferred Experience:


  • Evidence of interactions with health authorities, HTAs and/or payers
  • Background of presenting and publishing on the evolving health data landscape
  • Competency and/or awareness of standard statistical software such as SAS, R, Python and/or database programming language such as SQL
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations


Education/Qualifications:


  • Masters degree in quantitative science (e.g. Statistics, Health Informatics, Econometrics, Mathematics), Health Policy or Epidemiology
  • PhD in quantitative science would be preferred


Additional Information:


  • This is a full time, permanent position and can be based in the UK or Netherlands
  •  Please note there is no relocation or visa sponsorship aligned to this role





We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.