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Astellas Pharma Senior Manager, Real World Evidence Analytics in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Manager Real World Evidence Analytics opportunity in Northbrook, IL.

Purpose & Scope:

The Senior Manager, Real World Evidence Analytics is responsible for providing analytical expertise for economic, epidemiology and clinical outcomes projects using real-world databases (e.g, EMR, claims, etc.) across Astellas entire value chain geographic footprint and therapeutic areas. The Sr Manager will work with a group of Programmers, Analysts and Directors to design large and/or complex projects, interact with cross functional teams, and be accountable for delivering high quality outputs according to protocol and statistical analysis plans for the assigned projects.

Essential Job Responsibilities:

  • Support RWD&E Director by providing analytical support to the design, execution and publication of medical research projects using real-world data (e.g. claims, EMR, etc.)
  • Work with study team to define study objectives and measures/endpoints
  • Conduct exploratory analysis to identify suitable databases
  • Conduct feasibility analysis to enable timely development and approval of synopsis, protocols and SAP's
  • 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
  • Independently execute projects and effectively communicate progresses and challenges to other RWE team members during the execution of projects
  • Execute multiple concomitant RWE projects, including but not limited to, data generation in health economic, comparative effectiveness, real world data, patient reported outcomes, disease state and epidemiologic initiatives across therapeutic areas
  • Contribute to and/or lead the design, assessment and interpretation of RWE data in a statistically relevant context to support data needs for the company's portfolio
  • Ensure quality and consistency of key data science deliverables
  • Ensure that statistical analyses are performed in accordance with good statistical practice and applicable regulatory guidelines
  • Contribute to the development of Astellas RWE statistical processes and governance for database utilization, programming, and reporting actitivities
  • May provide statistical support for new product licensing and acquisition opportunities for marketed and late-stage compounds.
  • Provide analytics as a service for customers with non-RWE data

Quantitative Dimensions:

The Senior Manager, Real World Evidence Analytics provides economic, epidemiological and outcomes statistical analyses on observational databases, frequently but not always held by RWE, designed to inform either internal business decision making, or the medical value proposition for Astellas products throughout their life cycle. They are responsible for collaborating 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. The results produced by the Sr Manager Real World Evidence Analytics must be reproducible and statistically sound, and are subject to internal and external inspections.

Organizational Context:

The Senior Manager Real World Evidence Analytics reports to the Director, Real World Evidence Analytics as an individual contributor. They will collaborate closely with multiple project teams across Astellas functions, geographies and therapeutic areas. The Sr Manager will collaborate with the following colleagues across the entire Astellas value chain:

  • Medical affairs / Health economics
  • Regional commercial
  • Pharmacovigilance
  • Clinical Development
  • Strategic functions -- including product, portfolio and marketing strategy
  • Drug discovery research
  • External: Astellas partners, Vendors, Key Opinion Leaders

Qualifications:

Required

  • Master/PhD Degree in Statistics, Biostatistics, Epidemiology, or Mathematics and at least 3 years relevant experience with at least 2 years in support of pharmaceutical research
  • Experience in various types of RWE data including large clinical registries, insurance claims, electronic medical records, or pharmacy information sets
  • Advanced statistical modeling experience in either clinical trials, HEOR, or epidemiology research
  • Advanced programming skills in SQL, SAS and/or R
  • Demonstrable experience in generating analytic output relevant to business needs
  • Experience in working on project teams and managing projects within a matrixed environment
  • Advanced and broad knowledge of statistical methodology and understanding of industry practices related to the statistical analysis and modeling of clinical data
  • Experience with multivariate modeling and underlying data assumptions
  • Expertise in linear and non-linear regression modeling, survival analysis and Cox proportional hazard modeling
  • Excellent organizational, people, project and time management skills
  • Solid oral, written, and presentation communication skills (e.g. able to clearly communicate statistical and epidemiological issues and methods to statisticians and non-statisticians)

Preferred

  • Experience in the development & execution of RWE (observational) studies and/or peer reviewed manuscripts
  • Solid knowledge of Markov models and Bayesian statistics
  • Expertise in non-parametric statistics
  • Experience with processes and procedures in data management
  • Advanced meta-analysis capabilities
  • Working knowledge of common 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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Advanced Informatics & Analytics

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