Head, Clinical Biometrics at Astellas in Northbrook, Illinois

Job Description:

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 and Scope:

This position will provide vision, leadership and strategic direction for Biometrics (clinical trial biostatistics, exploratory biomarker statistics, PKPD statistics, statistical programming, methodology team, Benefit-risk PV stats team) globally to ensure consistent high quality quantitative approaches are applied at portfolio, project, and protocol level. In line with the mission for Development and Quantitative Sciences& Evidence Generation (QSEG), the position is accountable for the consistent development and advancement of the Biometrics expertise in Development, and for the successful application of this expertise globally in partnership with Japan-Asia Development, to all clinical phases of drug development in all Company's' therapeutic areas of focus.

As member of the QSEG leadership team, the Vice President Biometrics provides strategic and quantitative direction and input to ensure all key stakeholders such as clinical development team, PV, regulatory, clinical operation can consider the risks and likelihood of success of the options considered and ensures that across Development the scientific approaches are consistent with evolving regulatory guidance.

Essential Job Responsibilities:

Responsibilities and Accountabilities:

• Develops and implements the 1-3 year Statistics-specific objectives and plans. Participates in development of 3-5 year QSEQ vision, mission, objectives and plans.


• As the most senior statistical expert in Company, accountable for provision of statistical and quantitative input into the design and decision making for all development programs and clinical studies in Company's TA's of focus.


• Provide strategic high quality quantitative assessment of all due diligence efforts, and provide direction to development teams to ensure efficient development and protocol level plans are in place utilizing optimal statistical/quantitate approaches


• Accountable for the timely completion of all Biostatistics scientific and operational deliverables for development programs and clinical studies of all phases in Company's TA's of focus, in budget and with quality.


• Effectively delegates the responsibility for development and deployment of resources, while ensuring optimal oversight and supervision to ensure technical, leadership and team membership skills are maintained.


• Effectively works with Biostatistics TA heads, programming head(s) to manage the Functional Service Providers


• Accountable for creation and management towards statistics portion of annual departmental budget of approximately $5 Mill and external spend of approximately $10 Mill. Accountable for the operational delivery of all aspects of Biostatistics for Company's Therapeutic Areas for Phase I to Phase IV clinical trials, in line with timelines, budgets and quality expectations. Accountable for oversight of approximately 10 - 15 vendors globally for delivery of biostatistics services including niche vendors.


• Reports to the Senior Vice President of QSEG, member of the QSEG Leadership Team


• Functional leadership of the Statistics function globally (EU, Asian and US) with 6-8 direct reports, namely the heads of each TA in Biostatistics including Exploratory Development Biostatistics Head, Safety Biostats, Methodology biostats teams, Biostats programming Team, approximately 80 employees globally in Biostatistics and programming.