165002622516 - Biostatistics Director - Northbrook, IL | Biospace
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165002622516 - Biostatistics Director

Astellas Pharma Inc

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Location:
Northbrook, IL
Posted Date:
11/2/2016
Position Type:
Full time
Job Code:
2622516
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Director,

Job Description


Astellas is the bright spot in the pharmaceutical industry - not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine.

We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!

Astellas is announcing a Biostatistics Director, Location, Northbrook, IL

Purpose & Scope of Position:

The Biostatistics Director is a very senior biostatistician who provides technical statistical leadership to the biostatistics function and has a major influence on the technical capabilities of the department. May act as a global statistical lead (GSTATL), representing Data Science in Core Teams. Responsible for multiple projects, the Biostatistics Director works on the most complex or critical projects, discusses TA 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. Provides consultancy to other project teams and other GSTATLs, and advises staff on available statistical methodologies and their application in drug development ensuring the department stays at the forefront of statistical methodologies in drug development

Essential Job Responsibilities:

Technical Excellence:
•   Stays at the 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.

•   Advises project teams and GSTATLs on 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 help to clinical development issues.

•   Provides expert statistical strategy input to Core Teams and performs expert review of major deliverables

•   Facilitates and oversees creation of TA standards with respect to key variables, definitions, statistical methods, data structures and presentation of data

•   Provides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodies

•   Participates in reviewing in-licensing opportunities and due diligence activities, reviews data and advises company

Strategy:
•   Participates in development of 1 -- 3 year statistics-specific objectives and plans

•   Develops and implements plans to achieve objectives Leadership & People Development

•   Reviews key project level documents and advises other statisticians on design and methodologies

•   Advises staff on available statistical methodologies and their application in drug development

•   Coaches and supports GSTATLs in providing best in class data science support to Astellas drug development programs

•   Assists with recruitment, development / career management and retention of staff

•   Inspires and advises individuals in investigating and applying advanced statistical methods in drug development programs

•   Strategic thinker and problem solver, 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

Collaborations:
•   Leader or member of external industry or professional organizations. Develops and maintains relationships with leading academic institutions and key statistical opinion leaders

•   Actively participates in professional association activities to support the branding of Astellas

•   Ability to influence peers in same function, also in other sites

•   Ability to influence other peers and more senior managers inside and outside of GDO on best practice in their area of competence

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

Performance and Resource Management:
•   Perform vendor qualification/audits/training in collaboration with functional management

•   Measures and monitors performance standards in collaboration with functional management

•   Contributes to the development and implementation of quality programs Technology Development

•   Contributes 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

•   When assigned as GSTATL for clinical development programs and/or a lifecycle management of marketed products

•   Provides strategic statistical input to the project teams and is a major contributor to the clinical development plan (CDP). Ensures CDP with statistical integrity and optimal study designs.

•   Provides statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.

•   Ensures that Data Science needs are reflected within the development plan and strategy across regions. Leads the Data Science extended (project) team and deliverables teams. Ensures quality and consistency of key data science deliverables across studies. Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.

•   Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts / bodies

•   Reviews key project and study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, CDPs, protocols, analysis plans,   study reports, submission documents and correspondence with health authorities.

•   For studies within assigned projects provides ensures provision of all required statistical support and deliverables by supervising assigned study statisticians.

•   Ensures appropriate vendor oversight for assigned programs when statistical support or SAS programming for studies or other deliverables within assigned projects are contracted out to a CRO.

Quantitative Dimensions:
The Data Science department provides statistical, biometrical and data management/warehousing expertise for all R&D projects and marketed products, encompassing Phase I-IV studies. Qualified biostatistical expertise for clinical studies and drug submissions is a regulatory requirement, and carried out in accordance with international regulations (ICH, FDA, EMA) and internal Astellas SOPs and standards. The results must be reproducible and statistically sound, and are subject to internal and external inspections. Flawed statistical input to drug development projects may result in failure to achieve marketing authorization or regulatory approval delays resulting in substantial financial loss for the company.
A Biostatistics Director makes decisions and recommendations that could affect the methodology used across many of Astellas projects. He/she undertakes this work with full independence.

Organizational Context:
There are 5 biostatistician levels (excluding functional management roles). This is the 5th level. Reports to Associate Director / Director Biostatistics or Head Global Statistics and Programming. As a member of project teams, leads the data science extended (project) team and deliverables teams. Manages to achieve successful outcome through delegation of work, coaches assigned team members within own functions. Provides guidance to / mentors less experienced statisticians.


Requirements


•   M.S. or Ph.D. in statistics or equivalent area

•   Minimum of 10-15 years experience in applying statistical methods in biomedical research: extensive pharmaceutical or CRO experience required with at least 3 years managing projects for a product or a therapeutic area; academic or regulatory assessor experience preferred

•   Has demonstrated understanding of the pharmaceutical industry and related regulations globally; recognized as expert in application of biostatistics to clinical trials: e.g. leader/member of external industry or professional organizations, record of publications/presentations.

•   Advanced and broad knowledge of statistical methods, along with thorough understanding of industry practices related to the statistical analysis of clinical data

•   Expert level knowledge in a variety of statistical methods with applications in clinical development, or expert knowledge in one or more therapeutic areas

•   Experience in interactions with health authorities such as FDA or European regulatory bodies

•   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 working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.

•   Good understanding of the various functions and expert groups contributing to Drug Development

•   Knowledge and skills in SAS required and knowledge of other statistical software preferred.

•   Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.

•   Ability to work in a matrix environment.

•   Proven excellent organizational, project and time management skills.

•   Leadership skills and ability to delegate appropriately and provide direction to more junior Biostatisticians.

•   Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.

*LI-BR

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