Associate Director/Director, Biostatistics
Astellas

Job Info

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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 United States or Ontario, Canada. 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 and Scope:

The Associate Director / Director Biostatistics is a senior level statistician responsible for the supervision (Director level, in a matrix way) of other statisticians, provides statistical leadership and has a major influence on the technical capabilities of the department. This position works independently and involves the right level of participants as needed (Cross functional peers, Senior Management, Primary Focus Statistics Lead (PFSL)), effectively engaged as a matrix team member in Medical & Development (M&D). This position represents Astellas on statistical matters related to clinical data analysis or methodology at meetings with regulatory authorities, key opinion leaders and HTAs.

The Associate Director / Director Biostatistics has an extensive knowledge of his/her scientific area of responsibility; ability to ask critical scientific questions and to challenge hypotheses, designs and results interpretation. This position supports Senior Management with decision-making at the asset and portfolio level. Work has significant impact in terms of contributions to Statistics, and to other functions within Data Science, Astellas M&D and outside of the organization.

This position may act as global statistical lead (GSTATL) for a late phase or novel asset in the Cell and Gene Therapy development area, depending on relevant experience.

The Associate Director / Director Biostatistics challenges, assesses and discuss the asset strategy, supports interactions with regulatory authorities and key opinion leaders, and is accountable for the statistical soundness of all statistical input and deliverables for the assigned projects. The incumbent will demonstrate an understanding of Astellas' priorities and uses broad to advance Astellas' mission through high quality statistical work.

Although not a functional manager, the Associate Director / Director contributes in ensuring that Astellas is at the forefront of recruitment, training, professional development and retention of statistical personnel.

Essential Job Responsibilities:

• Accountable for multiple projects, providing leadership and advising project teams and statistical leads by challenging statistical design, analysis and decision-making issues
• Provides expert opinions, advises staff on available statistical methodologies, performs/supervises modeling and simulations, and 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
• Provides statistical leadership and consultancy to address authority requests, publication, presentation and other external sharing of results
• Reviews key project level documents and advises other statisticians on design and methodologies
• Contributes to or leads cross-functional or asset level improvement initiatives like development and implementation of best-in-class standards, processes and SOPs in statistics.
• Participates in due diligence activities, reviews data and advises company
• Remains current with cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, particularly with respect to the therapeutic area(s) of interest and signals relevant developments in a timely manner for the company.
• Researches, creates, validates, implements and teaches complex statistical methodologies ensuring the department stays at the forefront of statistical methodologies in drug development
• Coaches and supports statistical leads in providing best in class data science support to Astellas drug development programs.
• Inspires and advises individuals in investigating and applying advanced statistical methods in drug development programs.
• Challenges and influences peers and senior managers inside and outside of Data Science on best practice in their area of competence.

Organizational Context:

The Associate Director / Director Biostatistics is an individual contributor reporting to Primary Focus Statistics Lead (Executive Director).

With previous submission and regulatory interactions experience, the Associate Director / Director Biostatistics works on the most complex and critical projects from pre-Candidate Nomination (CN) till life cycle management impacting CN, POC, approval and post submission strategies.

Taking advantage of the matrix structure, the Associate Director / Director Biostatistics can independently contribute to the asset strategy in collaboration with the regulatory authorities and key opinion leaders and is accountable for the statistical soundness of all statistical input and deliverables for the assigned projects.

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