Astellas Pharma Senior Manager, Real World Evidence (RWE), United States Analytics in Northbrook, Illinois
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.
Purpose & Scope:
The Senior Manager, Real World Evidence Analytics provides analytical expertise for economic, epidemiology and clinical outcomes projects using real-world databases (e.g, EMR, claims, etc.) across Astellas value chain geographic footprint. Will collaborate internally across multiple products and therapeutic areas to provide statistical expertise, assessment and management for RWE projects. This includes projects across all products within the Oncology, Urology and Specialty / emerging / pipeline therapeutic areas.
Conduct feasibility analysis to identify suitable databases and enable timely development and approval of synopsis, protocols and SAP's
Work with study team to define study objectives and measures/endpoints
Develop statistical analysis and/or data modeling plans to support RWE projects and programs
Execute protocols and/or SAP's, conduct data programming and statistical analyses using SAS, R, SQL and other programs
Communicate progresses and challenges to other RWE team members during the execution of projects
Contribute to the interpretation of RWE data in a statistically relevant context
Ensure that statistical analyses are performed in accordance with good statistical practice and applicable regulatory guidelines
Contribute to the Astellas RWE statistical processes and governance for database utilization, programming, and reporting activities
Contribute to the development of complex macros to improve efficiency of project executions
The role reports to the Director, Real World Evidence Analytics as an individual contributor. Will collaborate with the following colleagues across the Astellas value chain: Medical affairs / Health economics, Regional commercial, Pharmacovigilance, Clinical Development, Strategic functions including product, portfolio and marketing strategy, drug discovery research, and external Astellas partners, Vendors, Key Opinion Leaders.
Master/PhD Degree in Statistics, Biostatistics, Epidemiology, Mathematics or other quantitative fields and at least 3 years relevant experience with at least 2 years in support of pharmaceutical research
Experience in Real World data including large clinical registries, insurance claims, electronic medical records, or pharmacy information sets
Advanced programming skills in SQL, SAS and/or R and macro development experience using SAS and/or R
Experience with linear and non-linear regression modeling, survival analysis and Cox proportional hazard modeling
Proven experience in generating analytic output relevant to business needs
Experience in working on project teams and leading projects within a matrixed environment. Excellent organizational, people, project and time management skills
Professional oral, written, and presentation communication skills, able to clearly communicate statistical and epidemiological issues and methods to statisticians and non-statisticians
Experience in the development & execution of RWE (observational) studies and/or peer reviewed manuscript
Advanced knowledge of statistical methodology and understanding of industry practices related to the statistical analysis and modeling of clinical data
Solid understanding of databases such as Pharmetrics, Optum, Premier, Truven, GE, Cerner, Symphony Patient Transactional data, IMS Health, CPRD, European country assets, Cegidim and others
Experience with Python, Tableau, Qlik, and other data analysis and visualization software
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation, Sick time, 40 Hours of Volunteer paid time off, national holidays, and paid year-end shutdown
401(k) Match and Annual Company Contribution
Company Paid Life Insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Annual Financial Wellness Allowance and Annual Wellness Reward
Long Term Incentive Plan
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Category Advanced Informatics & Analytics
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans