Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
About the role
- Senior Biostatistician supporting clinical evidence generation strategies in a medical technology company. Collaborating on studies in the Gastrointestinal and Surgical solutions sectors.
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.
Requirements
- 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
- 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.
- Must be able to travel up to 10% of the time.
Benefits
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**
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