- Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers analyses
- Translates scientific questions into statistical terms and is responsible for the quality and timeliness of corresponding statistical deliverables
- Independently provides statistical advice related to study design, selection of endpoints, population, PK/PD or biomarkers for routine studies.
- Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)
- Under the supervision of an experienced statistician, may support more complex studies or asset level analyses (i.e integrated summaries, regulatory, payer dossier and publications)
- Personal development / Collaboration
- Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).
- Collaborates and communicates effectively with the other Data Science functions; in particular the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables.
- Is responsible to develop a reliable network of academics, regulators and industry peers as well as investigate and share new statistical methodology.
- This position reports to a Director, Sr. Director or Executive Director.
- This position is an individual contributor role.
- This position is a hybrid position.
- This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics. This position is a member of the asset, study or other similar deliverable teams and closely collaborates cross functionally inside and outside Data Science
Senior Manager Biostatistics - Markham, Canada - Astellas
Description
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
This position is based in Ontario, Canada. 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 cross-functional teams, the primary purpose of the Senior Manager is to act independently as Study Statistician / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for routine works in an established area (clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project). The position can also act as a Senior Methodology statistician independently validating the execution of complex common techniques, offering training/consulting to other statisticians, or researching solutions for novel situations.
The position is expected to understand when to seek Global Statistical Lead (GSTATL) and/or line management intervention to ensure successful outcome with respect to resource requirements or key strategic functional issues. Under guidance, this position may act as GSTATL, or represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders, HTA or conferences.
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
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.