Manager, Biostatistics
Astellas

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.