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Olympus Corporation · 7 hours ago

Biostatistician

Center Valley, PA

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $160K/yr

6+ years exp

Olympus Corporation is a global medical technology company focused on enhancing healthcare through innovative solutions. The Biostatistician role involves providing analytical support for clinical studies and real-world evidence research, collaborating with various teams to generate clinical evidence and support health economic claims.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

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

Qualification

BiostatisticsStatistical programming SASStatistical programming RClinical trials experienceData analysisHealth economicsProject managementExcel proficiencyPowerPoint proficiencyInterpersonal skillsVerbal communicationWritten communicationCritical thinking

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, R

A 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

Strong verbal and written communication skills

Ability to coordinate and manage multiple priorities in a changing environment with minimal supervision

Strong skills in data analysis and the effective presentation of results

Advanced computer skill proficiency in Excel and PowerPoint is necessary

Critical thinking: Ability to provide detailed insight into potential health economics opportunities and challenges

Convincing and influencing skills: Ability to present information in a logical manner that address the need and concerns of the audience

Project management skills: Manage project goals timeline and milestones to assure on task deliverable schedules

Must be able to travel up to 10% of the time