Senior Manager Biostatistics - Markham, Canada - Astellas Pharma Inc.

Description

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/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 deliverablesIndependently 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.

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 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

Requirements

Qualifications:

Required

PhD or M.S in Biostatistics, Statistics or related scientific field

3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas

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

Good understanding of medical literature, clinical, regulatory, and commercial landscape

Ability to understand, implement, and explain complex statistical methodology

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

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