Senior Biostatistician

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

This role reports directly to the Director, Data Management and Systems collaborating closely with MCA – Medical Affairs and Clinical Affairs – as well as Health Economics and Market Access (HEMA) to run biostatistics and data management in support of clinical evidence generation strategies across the Gastrointestinal Solutions (GIS) / Surgical & Interventional Solutions (SIS) business unit portfolio.

 

The individual is to provide support on clinical studies and RWE research with cross-functional teams including internal and external business stakeholders within MSA, across GIS and SIS business units, and within the broader Olympus organization, as appropriate.

 

This individual will also conduct and develop plans for evidence-based literature reviews and identification of secondary sources to support health economic claims. 

Job Duties

• Serve as a primary analyst for clinical studies and RWE research using multiple clinical trial data and healthcare administrative data in support value proposition, abstract/manuscript submission.
• Prepare research findings for publication in peer-reviewed journals, conference presentations, and other dissemination channels.
• Manage multiple research projects simultaneously, ensuring they are completed on time, within budget, and in compliance with regulatory guidelines.
• Design statistical analysis plans for clinical studies and observational studies.
• Lead the design of clinical (and when relevant pre-clinical) studies: define endpoints, sample size/power, randomization strategy, and statistical methodology in support of proposal and protocol development.
• Oversee contracted statistical service vendors and provide direction of project scope and timelines. Develop contingency plans as necessary with regards to data analysis.
• Perform ad-hoc research and analysis requests on a variety of projects for Olympus business priorities including different evidence generation programs.
• Ensure compliance with regulatory standards relevant to medical devices (e.g., FDA, EMA, PMDA), quality systems/SOPs, data integrity and audit readiness.
• Lead or contribute to process improvement initiatives in biostatistics (methodology development, standardisation across studies, best practices)
• Perform programming or review of statistical programs (SAS, R, or other statistical software) to select/manipulate/analyse data; conduct QC of statistical outputs.
• Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs, medical writing, data management) to translate results for regulatory, scientific and commercial stakeholders.
• Perform all other duties as may be assigned from time to time by Management.

Job Qualifications

Required:

• Bachelor / Masters Degree in statistics/biostatistics, mathematics, Public Health or Health Care Services Research or related field is required.
• Minimum of 6 years previous in pharmaceutical/medical device industries or health care services research is required.
• Previous experience in statistics and its applications to clinical trials or observational studies, in academy or industry.
• An understanding of medical device purchase decision-making in the US.
• Proficiency in a statistical programming package such as SAS, RA strong work ethic to promote the development of life changing treatments for patients.
• Analytics skill set with experience in clinical studies or medical claims and other secondary data to generate patient safety, treatment efficacy and cost-effectiveness message is essential.
• Strong interpersonal skills and ability to motivate and influence others.
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