Senior Biostatistician

Olympus Corporation of the Americas•Upper Saucon, PA

2d•Hybrid

About The Position

This role reports directly to the Director, Clinical Data Management and Biostatistics collaborating closely with MSA – Medical Scientific Affairs – as well as Health Economics and Market Access (HEMA) to provide biostatistics support, and assist with clinical evidence generation strategies across the Olympus medical device 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 may also conduct and develop plans for evidence-based literature reviews and identification of secondary sources to support health economic claims.

Requirements

Bachelor or above degree in Biostatistics, Statistics, or a related quantitative field is required.
Minimum of 6 years of experience in statistical analysis and data interpretation in the medical device or pharmaceutical industry.
An understanding of medical device purchase decision-making in the US.
Proficiency in a statistical programming package such as SAS or R.
A strong work ethic to promote the development of life changing treatments for patients.
Proven track record of designing and executing clinical trials and studies.
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.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and present complex statistical findings to non-technical stakeholders.
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.

Responsibilities

Lead and oversee the design, implementation, and analysis of clinical trials for Olympus medical devices (i.e., conduct sample size and power analyses in support of proposal and protocol development).
Conduct statistical analysis and interpretation of data to support decision making for clinical trial protocols.
Collaborate with cross-functional teams (data management, study management, external vendors etc.) to ensure the quality and integrity of study data.
Manage multiple research projects simultaneously, ensuring they are completed on time, within budget, and in compliance with regulatory guidelines.
Develop statistical analysis plans and provide guidance on statistical methodologies.
Lead the creation, standardization, and implementation of biostatistical tools, methodologies, SOPs, and best practices to ensure consistent, high-quality statistical support across clinical programs.
Ensure compliance with regulatory requirements and guidelines in all statistical activities.
Maintain accurate and organized documentation of all statistical analyses and results.
Participate in the development of publications and presentations related to the clinical trial results.
Identify and implement process improvements to increase efficiency and effectiveness in statistical analysis
Liaise with HEMA, Market intelligence, and other teams to ensure appropriate clinical evidence support and guidance to align in the development of Value Propositions by acting as a subject matter expert for biostatistics within the organization.