Head, Medical Affairs Statistical Science

Job title:

Head, Medical Affairs Statistical Science

Company:

Astellas Pharma

Job description

Head, Medical Affairs Statistical ScienceAbout 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 Life Sciences 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 workingpractices, 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.The Opportunity:As a Head, Statistical Science, you should have a previous experience as line manager and an exceptional knowledge of the scientific area of responsibility, the position will require experience in complex and not well-understood statistical topics and/or disease states and/or RWD Science, as well as the ability to lead change and learn quickly technical topics.You are also expected to consistently and significantly impact the technical capabilities of the department and of the external scientific community.You will be responsible to support the key company priorities: BOLD, Growth Strategy and Sustainable Margin Transformation (SMT) which includes development and maintenance of excellence in portfolio, product and study design, optimal use of Real-World Data to support Medical Affairs tactics and development, analysis and reporting standards and innovative methodologies use.You will work independently and involves the right level of participants as needed (cross functional peers, Sr management, Primary Focus Statistics Lead (PFSL)) within or outside M&D. The position represents Astellas in interfaces with regulatory agencies globally, chair sessions in international statistics meetings, participate in industry-wide technical discussions and represent Astellas in professional societies.Hybrid Working:At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.Key Activities for this role:

• 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 modelling and simulations, leverages external experts to provide input to clinical development issues and 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
• Institutes best practice with regards to planning, execution, interpretation, publication, communication and regulatory/HTA submission of assets – Writes statistical position papers
• Challenges and influences peers and senior managers inside and outside of Data Science on best practice in their area of competence
• Coaches and supports statistical leads in providing best in class data science support to Astellas drug development programs.

Essential Knowledge & Experience:

• Substantial years of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
• Understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems, etc.)
• 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.
• 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.

Education/Qualifications:

• PhD or M.S in Biostatistics, Statistics or related scientific field.

Additional information:

• This is a permanent position in United Kingdom or Canada. Role requires a blend of home and minimum once a quarter in our Regional or Affiliate Astellas office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office

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.

Expected salary

Location

United Kingdom

Job date

Fri, 14 Feb 2025 23:15:56 GMT

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