Astellas Pharma Director Exploratory Biostatistics Development in Northbrook, Illinois
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:
Functional management of a group of approximately 2-4 statisticians responsible for all statistical aspects of drug development in the exploratory development area. This includes the responsibility for the development and maintenance of excellence in design, analysis, and reporting, and the successful application of statistical expertise to Phases 0 and 1 of drug development.
Reports to the Head of Biostatistics and Statistical Programming, is a member of the Statistics and Statistical Programming Leadership Team and contributes to the implementation of the DS mission, Biostatistics and Statistical Programming objectives and 1-3-year strategic plan. Contributes to the creation and use of an integrated single Data Science set of standards, processes and tools for the design, execution and reporting of clinical trials in M&D.
Responsible/Partner for development of strategic thinking in relation to Exploratory Development including biomarker, innovation labs, imaging, genomics and omics strategies; interfacing and point contact to Science groups within CPED (translational sciences, pharmacometrics, biomarker, modeling & simulation).
Partner with CPED and AIA to prepare the Integrated Evidence Generation Plan (IEGP); using specifically the EDAP process, identify data gaps and evaluate new preclinical and clinical data/information from internal and external sources relevant for further clinical development
Responsible for the technical development, allocation and management of Statistical resources including Phase I project and study statistician to M&D global project teams, extended teams and deliverables teams, respectively, for Exploratory Development projects.
Essential Job Responsibilities:
Participates in development of 1 -- 3-year statistics-specific objectives and plans
Develops and implements plans to achieve objectives
Identify new opportunities for lean, flexible and innovative approaches to accelerate drug development
Contributes to creation of budget for functional 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 approximately 2-4 individuals
Responsible for recruitment, development / career management and retention of staff
Coaches, develops and supports statisticians in providing best in class data science support to Astellas drug development and early clinical development programs
Provides oversight and guidance to study team members in completing study deliverables according to agreed timelines following quality standards
Performance and Resource Management
Manages and allocates 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
Manages training program of vendor staff in Astellas standards, processes, and systems
Oversight of vendors, manage metrics system such that deliverables are available on time according to Astellas standards and quality requirements
Reviews availability of sufficiently qualified vendor resources on a regular basis, contributes to planning of future vendor resource needs
Takes leading role in setting performance standards for Statistics Quality oversight
Oversee adherence to quality standards for work assigned to their members of staff
Responsible for compliance of direct reports with Astellas policies and procedures
Together with Head of Global Statistics and Statistical 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.
Inspires individuals while holding them accountable for project and study delivery, and to provide expert statistical input into development programs
Strategic thinker and problem solver within global statistics, 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
Strategic thinker and problem solver specifically in the Exploratory and Early Development arena, 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
Outstanding ability to think beyond traditional statistical approaches and bring an integrated quantitative approach to the strategic elements of drug discovery and development, working together with multiple quantitative and scientific disciplines
Ensures expert statistical strategy input is provided to Core Teams supported by direct reports
Performs functional management review of major deliverables and supports individuals in providing excellent statistical input into design, analysis and reporting of clinical studies
Facilitates and oversees creation of Phase I, indication-specific standards, biomarkers and omics standards with respect to key variables, definitions, statistical methods, data structures and presentation of data
Support Bioinformatics analyses involving clinical data (in partnership with Translational Medicine)
Provides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodies
Encourages and supports individuals in investigating and applying advanced statistical methods in drug development programs
Stays at the cutting edge of methodology development in early phase statistics, bioinformatics, biomarker and omics analysis. Expert in non-parametric, machine learning and Bayesian methods
Member of external industry or professional organizations
Leader of external industry or professional organizations
Develops and maintains relations with leading academic institutions and key statistical opinion leaders
Collaborates with CPED to ensure alignment in terms of Clinical Development Plans (CDPs), study design for clinical pharmacology and Proof-of-Concept studies and biomarker strategy
Collaborates and influence across locations and departments inside and outside of Development - ensuring excellence in study and project teams
Collaborates with Pharmacovigilance on all aspects regarding analysis and reporting of safety data
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
- May contribute to the design of an integrated information technology platform for Data Science and Development, especially in the area of analysis, reporting and data review tools, and database integration
Reports to the Head of Biostatistics and Statistical Programming. Member of Biostatistics & Statistical Programming leadership team. Functional management of a group of approximately 2-4 statisticians (individual contributors) with responsibilities for global projects and individual clinical studies.
MS or PhD in statistics or mathematics; minimum of 7-10 years in pharma or CRO industry, with minimum of 2-4 years in functional or project management role.
Minimum 3-5 years' experience working directly in the Phase I/Exploratory Development arena.
Minimum of 4-5 years of management experience including 2-3 years in a line management position
Demonstrated ability to translate strategic plan for Development, Data Science and Statistics into goals and objectives for 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
At least 2 years' experience in working on global clinical studies and projects or global process and system initiatives
Very good 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
Expert in methodology related to development in early phase statistics, bioinformatics, biomarker and omics analysis. Expert in non-parametric, machine learning and Bayesian methods
Experience with R programming, as well as WinNonlin and NONMEM, preferred
Good understanding of the various functions and expert groups contributing to Drug Development
Solid knowledge of SAS and other statistical tools
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
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans