Principal Clinical Statistician, Real World Data Analytics
Otsuka Pharmaceutical

Job Info

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Job Summary

Otsuka is looking for a strong Clinical Statistician in the Medical and Real World Data Analytics organization to provide statistical expertise for analysis of clinical trials data beyond the study endpoints, including secondary, exploratory, subgroup analyses. The overall purpose is to support evidence generation towards design new trials, assessing economic value, supporting health technology assessments through statistical analyses of clinical and other data. The role will manage the timely execution of statistical and research methodological components to meet project objectives and has a thorough understanding of current requirements for statistical standards.

Job Description

• Work closely with internal data scientists and data programmers, and external stakeholders including Medical Affairs, Value and Real World Evidence to provide end-to-end statistical expertise and delivery of analyses.
• Actively participate in project/study team meetings. Develop statistical sections of protocols; participate in mock-ups, review, and approve tables, listings and graphs specifications.
• Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and other external data. Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
• Work closely with clinicians, programmers, other statisticians, data scientists, and publication managers to generate QC outputs for publications, review publications to ensure accuracy, quality and soundness of statistical methodologies; coordinate, oversee and ensure quality delivery from vendors and their resources.
• Design statistical analysis, conduct statistical analysis and interpretation of analyses results. Ensure quality and timelines are met.
• Participate in study concept, protocol and SAP development for Real World Studies and ensure appropriateness of study design, sample size and statistical methodologies proposed.
• Author analysis plans, including table, figure, listing shells, and review reports. Develop cross-functional data review plan, key reports, and data dissemination plan in order to facilitate the review, summary, and dissemination of key study data/results.
• Contribute to external interactions with regulators, payers, review boards, etc.

Minimum qualifications

• A minimum of a Masters in statistics, biostatistics, econometrics, mathematics, or a related technical field
• A minimum of 5 years of experience within the pharmaceutical, healthcare or related Industry
• Experience with analyzing SDTM and ADAM datasets

Additional Knowledge, Skills and Abilities

• Deep understanding of clinical trials data, and its analyses using both classical and modern methodologies
• Strong statistical background demonstrated by publications and/or other achievements
• Hands on technical and project leadership with accountability
• Expertise in SAS and other statistical programming languages
• Experience with analyzing SDTM and ADAM datasets
• Strong technical writing, editing, and communication skills along with collaborative mindset
• Excellent organizational skills with an ability to embrace change and effectively manage multiple projects
• Ability to present and defend statistical analyses at Industry forums and regulatory agencies
• Experience with multiple therapeutic areas (e.g. CNS, renal, digital solutions)
• Strong technical writing, editing, and communication skills along with collaborative mindset
• Experience with design and analyses of observational studies, Health Economic data and research is strongly preferred
• Experience with latest statistical methods and Data Science
• Experience with mathematical modeling and simulation, epidemiology, health economic models

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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