Join Our Inclusive Team at Astellas

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!

About Astellas Pharma Inc.

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.

Position Details

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.

Key Responsibilities

The position is responsible to support the key company priorities:

• BOLD
• Growth Strategy
• Sustainable Margin Transformation (SMT)

This 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, chairs sessions in international statistics meetings, leads industry-wide technical discussions, and represents 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.

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

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.

Qualifications Required

• 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 and Primary Focus, 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.

Salary Range

$220K – $285K (NOTE: Final salary could be more or less, based on experience).

Working Environment

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.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

Category

Statistical & RWD Science

Astellas is committed to equality of opportunity in all aspects of employment... EOE including Disability/Protected Veterans