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:
The Senior Biostatistics Manager supports a statistics lead on one or more complex projects - and is fully responsible for multiple studies or other key deliverables within that project - and/or he/she acts as a statistical lead for local projects or global project in an established area under supervision of their manager or another more senior statistician. Leads data science deliverable teams. Interacts with vendors regarding progress and quality control of deliverables and instructs them on Astellas specifications. May mentor more junior statisticians. Is expected to complete the tasks with an appropriate level of independence, 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 for local projects or global projects in an established area and/or lifecycle management of marketed products.
* Provides statistical advice to project teams including design of studies and analyses and is a contributor to the project/product level strategy (for example, CDP, CMP, go/no go approach, OCs). Seeks peer/manager review within statistics to ensure that the Data Science needs are reflected in the strategy. Recognizes and addresses issues which may impact the statistical integrity of the development program.
* Ensures efficient planning, execution and reporting of clinical studies.
* Ensures quality and consistency of key data science deliverables across studies within a project. Supports 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, plans and conducts integrated analyses to support development decisions, submissions or marketing needs.
* Trains and coordinates statisticians within a project or a set of studies; May mentor more junior statisticians.
* May under guidance and supervision, represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts/bodies.
* Reviews protocols to ensure statistical integrity and optimal study designs. Writes the statistical sections of the study protocol.
* Reviews and provides input into critical documents as Study Team Member, such as CRFs and Data Validation Plans.
* Develops statistical analysis plans (SAPs), post hoc analysis plans and tables, listings, and figure (TLF) specifications.
* Performs statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
* Implements study analyses, including reviewing data specifications, providing programmers with efficacy analyses algorithms, programming or QCing inferential statistical analyses and reviewing outputs and analysis results.
* Interacts with programmers in the coordination of data summaries and analysis activities.
* Leads and organizes review meetings, such as TLF review meetings, and classification meetings.
* Writes (executive) topline reports.
* Contributes to clinical study reports, regulatory and payer dossier and publications and provides statistical interpretation of the results.
* Influences (consider internal, external and beyond project) project team members from all disciplines on statistical design and methodology topics.
* When statistical support or programming for studies or other deliverables are contracted out to a CRO.
* Contributes to selection of vendors.
* Provides CRO with study details and timelines. Instructs CRO on Astellas standards, specifications and provides appropriate documents and data, and ensures that CRO is updated in case of changes.
* Interacts with vendors regarding progress and quality control. Monitors timelines and progress and takes action as appropriate.
* Reviews outputs and reports created by the CRO for validity and completeness.
* Familiar with the contract specifications and communicates any out of scope requests appropriately.
Other tasks and roles
* Contributes to cross-departmental/departmental/sectional improvement initiatives, for example:
* write SOPs, select, validate and implement statistical software; generate output or analysis methods
* Investigates new statistical methodology and educates the department.
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, PMDA,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 substantial regulatory approval delays resulting in substantial financial loss for the company. A Senior Biostatistics Manager undertakes work independently in an established area, and under guidance for complex or novel projects.
There are 6 biostatistician levels (excluding functional management roles). This is the third level. The Senior Biostatistics Manager reports to the Associate Director / Director Biostatistics. Works independently on local projects or global projects in an established area or under the supervision on more complex or novel projects. Is a member of project and/or study or other deliverable teams. Closely collaborates with project and study team members (e.g. programmers, data managers, clinical study managers, study medics, HEOR, regulatory affairs, clinical pharmacology, project management, global medical lead). May mentor more junior statisticians.
* MS or Ph.D. in Statistics or equivalent degree/experience
* Minimum of 5 years of experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry experience required or demonstrated ability to provide statistical direction in these areas
* Advanced knowledge of statistical methods for design of clinical studies and analysis of clinical data
* Very good oral and written communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.
* Ability to interact across different cultures, builds global relationships.
* Accurate and keen eye for detail. Dedication to quality and reliability in all work tasks
* Very good interpersonal skills to effectively work in cross-functional project teams
* Good knowledge and skills in SAS required and knowledge of other statistical software preferred
* In depth familiarity with processes and procedures in data management and programming
* Good organizational, project and time management skills.
* Oncology experience preferred by not required.
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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