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:

　　Member of the extended statistical team, the primary purpose of the Manager is to contribute to the design, analysis, and reporting of clinical trials/observational studies under the supervision of a more senior Statistician. The position can also act as a Methodology Statistician independently validating the execution of routine common statistical technique and identifying situations where novel techniques may be appropriate.

　　The position is expected to complete routine tasks with an appropriate level of independence and in accordance with the project direction and standards. For more complex tasks, the position works under the supervision of a more senior Statistician.

　　Essential Job Responsibilities:

　　Astellas is looking for diverse talents, self-motivated and eager to make a difference for the patients, therefore responsibilities listed below are characteristic of the type and level of work; not all are expected to be carried out.

　　Contributes to the efficient planning, execution and reporting of clinical or observational studies, post hoc, HTA, regional, PK-PD or Biomarkers analyses with an appropriate level of independence

　　Is responsible for the quality and timeliness of all statistical deliverables of the assigned tasks

　　Authors / reviews: synopsis, protocol, statistical analysis plans (SAP), Case Report Forms (CRF), Data Validation Plans, tables listings and figure (TLF) specifications

　　Performs statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.

　　Reviews all outputs for validity and completeness. QC inferential statistical analyses.

　　Monitors timelines and progress, leads and organizes review meetings, such as TLF review meetings, and classification meetings.

　　Contributes to clinical study reports, other reports or publications by providing statistical interpretation of the results.

　　Personal Development / Collaboration

　　Collaborates with other study team members (e.g. programmer, data manager, clinical study manager, study medical lead) influencing team members from all disciplines on statistical design, analysis and methodology topics

　　Partners and communicates effectively with other Data Science (DS) functions; in particular provides Statistical Programmers with study details, timelines, specifications, and efficacy analyses algorithms. Statistician and Programmer communicate frequently and update each other on progress of individual deliverables.

　　Develops expertise beyond statistics by researching medical literature, understands clinical, regulatory, and commercial landscape and builds an adequate network with academic, regulators and industry peers

　　Keeps current on statistical methodology and programming skills

　　Organizational Context:

　　Part of the Data Science Division (DS), Statistical & Real World Data Science (SRS) is a global, diverse, comprehensive and inclusive group of quantitative scientists who design Astellas’ development programs to allow data-driven decision-making. From candidate nomination through to commercialization and in close partnership with the Primary Focus Divisions, Medical Affairs and Early Development, SRS is accountable for all statistical aspects globally

　　Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.

　　This position reports to a Director, Sr Director or Executive Director.

　　This position is an individual contributor role.

　　This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics in SRS and a member of a deliverable team.

　　Qualifications:

　　Required

　　PhD in Biostatistics, Statistics/related scientific field with internship experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry OR S in Biostatistics, Statistics/ related scientific field with 3+ years of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry

　　Good knowledge and skills in SAS required, knowledge of R preferred

　　Understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems)

　　Understanding of and experience with pharmaceutical datasets, statistical methodology, P,V and NIPASS from data identification landscaping, etc.; Understanding of how to transform research objectives into study design, regulatory publications, and abstracts

　　Working knowledge of pharmaceutical vendors/CROs and how they are used to execute on Data Science activities

　　Understanding of the DS lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization process, etc.)

　　Understanding of statistical principles, methodology and algorithms (including analyzing and interpreting data in a research environment)

　　Understanding of how data is being used and applied (e.g., models), what DS is doing across different activities for a product, and how DS is building something bulletproof from an evidence perspective

　　Hands-on programming experience within one or more statistical/data science programming languages (e.g., R, SAS, or Python) – including data manipulation and analysis of a wide array of data sources/types

　　Understanding of and experience with how to read, interpret, and communicate scientific concepts/data; Understanding of observational methods

　　Shows ability to read, analyze, and communicate large and small amounts of data effectively including teaching/explaining data-driven results to others; Applies experience that can span across statistical modeling, data mining, descriptive statistics, and other data analysis techniques

　　Understands and clearly communicates the goals of internal teams and external stakeholders (i.e., vendors), and their expected impact to the project/study; Ensures they meet their goals and expectations; Ensures cross-functional and cross-divisional collaboration; Shows ability to deliver through others

　　Identifies and communicates project goals, timelines, and milestones; Identifies project interdependencies and potential constraints; Assigns roles and holds stakeholders accountable to meet project outcomes on time and within budget

　　Effectively leverages negotiation strategies and tactics to reach solutions both internally and externally; Influences others positively and effectively through project team decisions (e.g., opportunity costs, other viewpoints, alternative solutions, etc.)

　　Identifies/implements new ideas and methodologies, learn new techniques, and adjust to new methodologies quickly

　　Skilled at finding and analyzing logical flaws/gaps in plans and processes; Identifies problems and solutions that others might miss; Provides detailed insights and constructive criticism into problems and complex situations; Works autonomously and takes initiative

　　Works autonomously and takes initiative, Proactivity

　　Benefits:

　　Medical, Dental and Vision Insurance

　　Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

　　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

　　#LI-SS

　　Category Statistical & RWD Science

　　Astellas is committed to equality of opportunity in all aspects of employment.

　　EOE including Disability/Protected Veterans