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Astellas is announcing a Associate Biostatistics Director (Oncology), Location, Northbrook, IL
Purpose & Scope of Position:
The Associate Biostatistics Director acts as fully independent global statistical lead (GSTATL), representing Data Science in Core Teams. May be responsible for one or for multiple global or local drug projects within the same indication / therapeutic area. Leads large and/or complex projects, interacts with regulatory authorities and key opinion leaders, supervises other statisticians providing support to the projects 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 in areas of expertise. Is expected to complete these tasks with very minimal supervision, appropriately and pro-actively seeking line management intervention where needed to ensure successful outcome, e.g. with respect to project resource requirements or key strategic functional issues.
Essential Job Responsibilities:
• Participates in project teams for clinical development programs and/or 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, and ensures that Data Science needs are reflected within the development plan
and strategy across regions. 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.
• Provides best in class data science support to Astellas drug development programs and 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.
• Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
• 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, clinical development plans (CDPs), protocols, analysis plans, study reports, submission documents and correspondence with health authorities.
For studies within assigned projects
• Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.
• Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports.
• Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTM/ADaM data specifications, TLFs
• Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
• Provides (executive) top line reports of study results
When statistical support or SAS programming for studies or other deliverables within assigned projects are contracted out to a CRO:
• Contributes to vendor selection.
• Performs vendor oversight for assigned programs: Ensures CRO is provided with details, timelines and Astellas specifications and requirements and kept up to date in case of changes. Monitors timelines, progress and specific issues, and takes action if necessary. Ensures review of the outputs created by the CRO.
Other tasks and roles may include:
• Major contributor to cross-departmental/departmental/sectional improvement initiatives, for example: write SOPs; select, validate and implement statistical software; generate standard output or analysis methods.
• Member or leader of external industry or professional organizations. Develops and maintain relations with leading academic institutions.
• Perform vendor qualification / audits in collaboration with functional management
• Investigates new statistical methodology and feeds back to department and project teams
• Participates in due diligence activities, reviews data and advises company.
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.
An Associate Biostatistics Director is assigned to approximately 1-6 compounds simultaneously in 1-3 indications, and oversees between 4 and 12 studies simultaneously. Undertakes this work with minimal supervision.
• M.S. or Ph.D. in statistics or equivalent area.
• Minimum of 8 years experience in applying statistical methods in biomedical research, extensive pharmaceutical or CRO experience required
• Experience in working on clinical project teams. Good understanding of entire drug development process - ability to see the big picture.
• Experience as the independent lead statistician in a regulatory submission preferred
• Experience with cross functional process improvement or innovation initiatives
• Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data
• Knowledge and skills in SAS required and knowledge of other statistical software preferred.
• In-depth familiarity with processes and procedures in data management and SAS programming
• 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.
• Very good problem solving skills.
• Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks
• Ability to perform under pressure
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled