Head, Medical Affairs Statistical Science (Sr. Director)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose :

As a very senior SRS member, this position is part of the SRS LT or part of the LT of an SRS LT member and manages an organization responsible for a field in SRS across PF and regions (e.g. Medical Affairs Statistics, Early and Exploratory Statistics, Innovative Statistics, Real World Data Science, statistical programming), or directs global clinical development statistics for one or more PF.

With 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. The position is expected to consistently and significantly impact the technical capabilities of the department and of the external scientific community.

The position is 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.

The position represents Astellas in interfaces with regulatory agencies globally, chair sessions in international statistics meetings, leads industry-wide technical discussions and represent Astellas in professional societies.

The position can act as a deputy for the Primary Focus Statistics Leads (PFSL) or as a Fellow, supporting 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.

The position works 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.

Essential Job 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.
• Institutes best practice with regards to planning, execution, interpretation, publication, communication and regulatory / HTA submission of assets - Writes statistical position papers.
• Stays at the cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, particularly with respect to the Primary Focus of interest, and signals relevant developments in a timely manner for the company.
• Challenges and influences peers and senior managers inside and outside of Data Science on best practice in their area of competence.

Personal development / Collaboration