Biostatistician
Olympus Corporation of the Americas
full-time
Posted on:
Location Type: Office
Location: Center Valley • Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $92,499 - $129,498 per year
Job Level
Mid-LevelSenior
About the role
- 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
- 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.
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**
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysisclinical trial data analysisobservational studiesdata analysisprogramming in SASprogramming in Rstatistical methodologysample size determinationrandomization strategyquality control of statistical outputs
Soft skills
strong work ethicinterpersonal skillsverbal communicationwritten communicationability to manage multiple prioritiesmotivation skillsinfluence skillsorganizational skillsadaptabilityteam collaboration