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Senior Director, RWDE Chief Methodologist

Northbrook, IL, USA | Astellas Pharma

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    10-12 years
Job Description:
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Astellas is announcing a Senior Director, RWDE Chief Methodologist opportunity in Northbrook, IL.


Purpose & Scope:


The Senior Director, Real World Data & Evidence(RWDE) Chief Methodologist provides overall methodologic leadership and oversight for the analyses conducted within the global RWDE organization at Astellas. This person is a subject matter expert in the areas of empirical methods for real world data used in life science, including Health Economics & Outcomes Research, Epidemiology, Causal Inference, Machine Learning and Operations Research. They will interact with cross functional teams and provide methodological support to projects across all Astellas therapeutic areas, functions and geographies. They are responsible to maintain state-of-the-art empirical methods and provide consultation to Research Directors, Statistical Leads, and Analysts on the design of their real world evidence projects including protocolized Medical Affairs and Market Access studies, clinical trial design support analyses, biomarker development, and patient segmentation and targeting strategies. The RWDE Chief Methodologist is also accountable for the analytical soundness of project plans, output and deliverables for all RWDE projects.


This position will also be responsible for developiong new methods and educating and training staff on alternative approaches to analyze real world data and requires proficiency in effective leadership as well as people and project management skills. Specifically, this position will


ensure that analytics methods for all projects are valid, appropriately implemented and aligned with the project objectives;

establish effective communication with all internal stakeholders to understand and support the RWDE analytical and statistical needs of the business; and

support collaborations with other analytic functions across Astellas, including Data Sciences, Translational Science and Clinical Pharmacology & Early Development, and Pharmacovigilance.

provide oversight for selected statistical analysis across multiple external database vendors and experts to ensure that Astellas sponsored RWDE initiatives are clinically relevant, address potential market demands and support the needs of patients, health care providers and payers.


Essential Job Responsibilities:


Provide oversight of RWDE statistical/analytical expertise and input for RWDE projects/initiatives, protocol development, regulatory documents, scientific publications, and independent research proposals across multiple teams in all therapeutic areas for both in-line and development products

Assist RWDE Head to identify and prioritize multiple RWDE initiatives for analytics and methodologies, including but not limited to: new software / analytic tool assessment and acquisitions, new tool development, automation and machine learning.

Remain current with evolving use of Machine Learning, Artificial Intelligence and Natural Language Processing in the development and use of real world data sources for the life sciences industry and help establish Astellas' reputation in this space

Ensure quality and consistency of complex analytics deliverables by providing methodological support and training to key staff members

Ensure that statistical analyses are performed in accordance with good statistical practice and applicable regulatory guidelines

Ensure team members have a robust understanding of advanced analytics methodologies and contribute to predictive modeling standards, data analyses techniques and model managements

Support strategic analytics collaborations with Astellas Global/regional colleagues and external partners to advance RWDE initiatives as appropriate

Serve as the methodology expert (go-to resource) for RWDE analytics across all datasets and applications


Quantitative Dimensions:


The RWDE Chief Methodologist provides methodologic / statistical support for all complex analyses in RWDE. They are responsible for collaborating with internal and external stakeholders across multiple products and therapeutic areas to provide statistical expertise, assessment and management. The results produced by the RWDE Chief Methodologist must be reproducible and statistically sound and are subject to internal and external inspections.


The RWDE Chief Methodologist will oversee this work with minimal supervision but reporting into the Head of Real World Data & Evidence.


Organizational Context:


The RWDE Chief Methodologist reports to the Executive Director, Head of Real World Data & Evidence. There are no direct reports for this position. They will collaborate closely with multiple project teams across all RWDE and priority areas. The RWDE Chief Methodologist will collaborate with the following colleagues:


RWDE Directors and Regional Leads

RWDE Statistical Leads

RWDE Strategy & Alliances Lead

MA Global HEOR: Senior Directors

MA Regional HEOR: Senior Directors & Directors

Data Sciences: Senior Directors & Directors

External: Astellas partners, Vendors, Key Opinion Leaders


Quantitative Dimensions:


The RWDE Chief Methodologist provides methodologic / statistical support for all complex analyses in RWDE. They are responsible for collaborating with internal and external stakeholders across multiple products and therapeutic areas to provide statistical expertise, assessment and management. The results produced by the RWDE Chief Methodologist must be reproducible and statistically sound and are subject to internal and external inspections.


The RWDE Chief Methodologist will oversee this work with minimal supervision but reporting into the Head of Real World Data & Evidence.


Organizational Context:


The RWDE Chief Methodologist reports to the Executive Director, Head of Real World Data & Evidence. There are no direct reports for this position. They will collaborate closely with multiple project teams across all RWDE and priority areas. The RWDE Chief Methodologist will collaborate with the following colleagues:


RWDE Directors and Regional Leads

RWDE Statistical Leads

RWDE Strategy & Alliances Lead

MA Global HEOR: Senior Directors

MA Regional HEOR: Senior Directors & Directors

Data Sciences: Senior Directors & Directors

External: Astellas partners, Vendors, Key Opinion Leaders


Qualifications:


Required


PhD. in Statistics, Epidemiology, Econometrics or other quantitative fields like Mathematics or Computer Science (requires minimum 10 years' experience)

Minimum of 8 years' experience in leading the design and implementation of statistical/quantitative methods in biomedical research, extensive applied data mining and modeling experience

Advanced and broad knowledge of statistical and data science methodology and strong understanding of industry practices related to the statistical analysis and modeling of real world data including administrative claims, EMR and laboratory results.

Extensive experience in the development & execution of HEOR and Market Access studies and/or peer reviewed manuscripts

Advanced knowledge in multivariate modeling including linear and non-linear regression modeling, data reduction methods, data mining and machine learning techniques. Special emphasis on classification and segmentation methods

Data modeling experience using SAS, R or other statistical programming languages

Experience in working on project teams and managing projects and people within a matrix environment

Experience with processes and procedures in data management, data standards such as CDISC, OMOP and SAS programming

Excellent organizational, 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


Deep knowledge of data mining tools such as SAS, R, Python as well as proficiency in SQL

Deep knowledge of machine learning algorithms and the application of artificial intelligence models to life sciences development problems

Expertise in causal inference, missing data and text-mining


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