Senior Director - Biostatistics - Oncology - Astellas - Northbrook

Job description
Purpose & Scope of Position:
*Responsible for directing statistical operations and strategy, development and maintenance of excellence in data design, analysis and reporting standards, methodologies, application and support for the Oncology therapeutic area; and for the successful application of this expertise globally (EU and US)


*Reports to the head of Biostatistics & Clinical Programming, is a member of the Biostatistics & Clinical Programming leadership team and contributes to the development and implementation of the Biostatistics & Clinical Programming mission, objectives and 3-5 year strategic plan and participates in the creation and use of an integrated single GDO set of standards, processes and tools for the design, execution and reporting of clinical trials in APGD.
*Responsible for the optimal development, allocation and management globally (EU and US) of Statistical resources for the assigned therapeutic area(s) including Global Statistical Lead, project and study statistician to APGD global project teams, extended teams and deliverables teams, respectively.

Essential Job Responsibilities
Strategy
*Contributes to the development and implementation of 1-3 year Biostatistics and Programming-specific objectives and plans.
*Effectively collaborates with Medical TAHs and staff for assigned TAs to ensure 1) Therapeutic area specific best-in-class knowledge, application, and molecule strategic context is reflected in Biostatistical expertise; 2) that Biostatistical and Programming resources and deliverables meet and exceed their expectations of context, project team participation and behavior, quality and timeliness of deliverables; 3) optimal review and management of Biostatistical input at project review governance; and 4) appropriate training and sharing of specific therapeutic area and applicable statistical knowledge and innovation within Biostatistics.
*Ensure therapeutic alignment with other GDO functions, TAHs for assigned TAs, Pharmacovigilance, Regulatory Affairs, CPED and Medical Affairs in the development of clinical development plans, protocol, CSR, ISS and ISE standards and processes. Effectively collaborates with Regulatory Affairs to ensure optimal strategic and quality input and delivery in planning of clinical development strategies, execution of clinical trials and in the preparation and submission of relevant regulatory dossiers, documents, presentations, responses and specialty publications. Effectively collaborates with Product/Drug Safety and Pharmacovigilance to assure compliance with standards and process for the collection, analysis and communication of human safety information, ensuring safety of all patients receiving investigational and or marketed Astellas products.

*Support the Head, Global Biostatistics & Clinical Programming, in the creation of budget for the Biostatistics area; maintains awareness of budget status, and contributes to the management of the entire Data Science / Statistics & Programming budget in line with agreed targets

People Management and Development
*Direct supervision of 2-5 staff; indirect supervision of up to approximately 20 individuals
*Responsible for recruitment, development / career management and retention of staff
*Coaches, develops and supports functional managers and staff in providing best in class data science support to Astellas drug development programs, and in leading extended and deliverables teams
*Provides oversight and guidance to program leads in completing project and study deliverables according to agreed timelines following quality standards
*Participates in development and maintenance of competency framework, training programs, and attract and retain best in class Biostatistics expertise. Contributes to the development and maintenance of competence and training for Biostatistics.
*Participates in design and implementation of optimal organizational structure which maximizes on the use of resources globally and reflects the therapeutic area focus in APGD.

Performance and Resource Management
*Ensure optimal allocation of internal and external resources to projects
*Measures and monitors performance standards
*Oversees adherence to timelines, standards, processes for work assigned to their members of staff
*Contributes to the development and implementation of quality programs
*Takes leading role in setting performance standards for Biostatistics

Quality oversight
*Oversee adherence to quality standards for work assigned to their members of staff
*Responsible for compliance of direct and indirect reports with Astellas policies and procedures
*Together with Head of Global Biostatistics and Clinical Programming and other senior Data Science leaders, provides input into annual audit plan, and establishes and follows up on Corrective and Preventative Actions in response to audit reports issued by Clinical QA.

Leadership
*Inspires individuals, including functional managers at the (associate) director level, while holding them accountable for project and study delivery, and to provide expert statistical input into development programs
*Strategic thinking and problem solving at a cross-functional level; who recognizes, anticipates and solves problems; helps individuals to develop problem solving skills. Must be able to delve into high degree of detail when necessary

Technical Excellence
*Ensures expert statistical strategy input is provided to Core and Extended Teams supported by direct and indirect reports
*Performs functional management review of major deliverables and supports individuals in providing excellent statistical input into design, analysis and reporting of clinical studies
*Participates in the creation of TA or indication-specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of data
*Provides oversight and insight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodies
*Encourages and supports functional managers and individuals in investigating and applying advanced statistical methods in drug development programs
*Stays at the cutting edge of methodology development in statistics
*Leader or member of external industry or professional organizations Develops and maintains relations with leading academic institutions and key statistical opinion leaders.

Collaborations
*Responsible for collaboration with TAH and GDPLs to ensure common knowledge platform for assigned TAs and development programs
*Collaborates with Medical Affairs and HEOR to enable collection and communication of Health Economics and Outcomes Research data
*Ability to influence outside their function, also more senior managers inside and outside of GDO on best practice in their area of competence
*Collaborates across locations and departments inside and outside of GDO - ensuring excellence in study and project teams * Collaborates with Product / Drug Safety and Pharmacovigilance on all aspects regarding analysis and reporting of safety data

Process Development
*Contribute to improvement efforts, implements agreed improvement actions and monitors effects after implementation
*Contribute to development and implementation of best in class standards, processes and SOPs in statistics
*Leads strategic improvement projects

Technology Development
*May contribute to the design of an integrated information technology platform for GDO, especially in the area of analysis, reporting and data review tools, and database integration
*Contributes to the development and maintenance of global platforms, solutions and vendor relationships for the design, capture, analysis, integration and reporting of drug development related data; for the use of relevant external data, and data models and which ensure APGD and Astellas maintains and protects its product information optimally.
*Collaborates with other GDO functions, and other functions in APGD and Astellas to ensure development and maintenance of appropriate tools for the management and assessment of project performance.

Organizational context

Reports to the Head of Global Biostatistics and Clinical Programming. Member of Biostatistics & Clinical Programming management team. Direct supervision of 2-5 staff; indirect supervision of up to 20 individuals globally.

*MS, preferably PhD, in statistics or mathematics; minimum of 10-12 years in pharma or CRO industry, with minimum of 5+ years in functional or project management role including 2-3 years in a line management position

*At least 5+ years experience in working on global clinical studies and projects or global process and system initiatives

*Excellent understanding of all phases of clinical development, and processes in data science

*Experience in all aspects of statistics for clinical trials, and in working as a member of a project team including design of clinical studies and contribution to Clinical Development Plans

*Experience as lead statistician for multiple submissions to health authorities, substantial experience in interactions with health authorities

*Proven leadership for and in-depth understanding of one or more TA's within Biostatistics, including statistical methodology, competitive landscape and business environment

*Proven ability to manage managers

*Demonstrated ability to lead independently

*Excellent understanding of the various functions and expert groups contributing to Drug Development

*Solid knowledge of SAS and other statistical tools

*Demonstrated ability to translate strategic plans into goals and objectives for their own function

*Demonstrated leadership skills and ability to effectively prioritize own group's activities for development projects and clinical trials

*Proven ability to establish operating guidelines and procedures, preferably in a global setting

*Demonstrated ability to successfully identify and lead global process or system improvement initiatives

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