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Job ID

389458BR

About the role

Role Purpose

The Data Science Specialist in the Real-World Evidence & Evidence Excellence (RWE&EE) team is responsible for providing strategic guidance and analytical approaches to evidence generation initiatives, particularly in the areas of clinical research, post-marketing studies, real-world data, and evidence. They will act as a partner to the Medical Franchise teams, Health Economics and Outcomes Research (HEOR) team, and Global Drug Development (GDD) to lead evidence generation efforts and contribute to the development of integrated medical plans and early medical strategies within Novartis.

Major Accountabilities

  • CONTRIBUTE TO THE DESIGN AND ANALYSIS OF RWD

o Co-lead Data generation planning, implementing and delivering high quality, scientifically robust observational and/or Clinical trial design (i.e. target population, protocol development, sample sizing)

o Evaluate and assess strengths and weaknesses of external Real World Data sources for advancing the data strategy for a given therapeutic area.

o Design a fit-for-purpose analysis plan by considering validity and generalizability of data and results, assess effective ways of delivering the results to maximize impact and interpretability.

o Operate in collaboration with study personnel to provide statistical considerations on study design.

o Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the data analysis.

o Maintain accuracy with respect to statistical methodology, to maintain proficiency in applying new and valid methods, and to be competent in justifying methods selected.

  • RECOMMEND DATA SOLUTIONS to address evidence needs.

o Ask the right scientific questions, understand the evidence needs and make recommendations on fit-for-purpose data and analytics solutions.

o Leverage RWD and technology to propose solutions for enhancing medical practice and patient outcomes (e.g., engagement platforms, TPO dashboard etc.)

  • Contribute to and engaged in the Integrated Evidence Plan in collaboration with Medical Affairs team and Evidence Generation team in RWE&EE (Evidence Generation team).
  • Effectively facilitate planning, execution and analysis phase on RWE projects in collaboration with Evidence Generation team to ensure fit-for-purpose design and analysis.
  • Lead analytical considerations on and facilitate reporting analysis results from evidence generation activities.
  • Lead to build Local Real World evidence generation capability and expertise.
  • Ensure compliance to Good Clinical Practices (GCP) and internal procedures in collaboration with MGL.
  • Build an internal global-regional-local network to share best practices.
  • Engaged in SRB Office as a strategic partner.

Position Title

Lead / Senior Lead, RWE (Bio Statistics Specialist)

Role Requirements

Education:

  • Master’s degree or equivalent experience on statistics, computer science, public health sciences or related field.

Languages:

  • Fluent in Japanese and English (business level)

Experience/Professional requirement:

  • More than 3 years of experience in the pharmaceutical industry, CRO or academic institute with knowledge in statistics, data science and/or RWE activities, and preferably knowledge of statistical analysis programming.
  • Experience with analytical activities, e.g., statistical analysis, on clinical development, clinical research, and preferably knowledge of data management.

Competency

  • Deep understanding of Medical Affairs or Market Access/ HEOR, Safety or related disciplines to generate value evidence from retrospective and prospective studies.
  • Deep understanding of available and emerging RWD data sources in Japan.
  • Good knowledge in statistics, regulatory guidelines, and about clinical development
  • Considerable experience in planning, creation, and analysis of real-world data, from both prospective and retrospective studies
  • Demonstrated ability to engage a complex matrix of internal and external stakeholders to identify and articulate evidence needs and gaps and define RWE plans to address them.
  • Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and valid methods, and to be competent in justifying methods selected.
  • Logical, critical thinking and strong problem-solving skills

Job Type

Full Time

Country

Japan

Work Location

Tokyo

Functional Area

Research & Development

Division

International

Business Unit

Japan IMI

Employment Type

Regular

Company/Legal Entity

Novartis Pharma K.K.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Read Full Description
Confirmed 22 hours ago. Posted 30+ days ago.

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