Biostatistician

3 days ago

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Exactech

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Exactech is a global medical technology company that empowers orthopaedic surgeons with innovative implants, surgical instruments and the Active Intelligence® (AI) ecosystem of smart technologies to give patients EXACTLY what they need to regain mobility$1. .$1

Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation

501 - 1000

Description

• The biostatistician role provides biostatistics planning and support to Exactech research initiatives. • Collaborating with team members on study design development for clinical protocols, including preparation of statistical analysis plans and sample size calculations for clinical studies. • Providing statistical input for Clinical Investigation Plan (CIP) and Case Report Form (CRF) development. • Performing statistical validation of Electronic Data Capture (EDC) dataset output to verify accuracy. • Performing statistical analyses of clinical outcomes data, including survivorship analyses (e.g., Kaplan-Meier). • Preparing and reviewing statistical data analysis sections of clinical research reports, including statistical methodology, efficacy/performance and safety results. • Engaging in statistical consulting projects with Exactech clinical investigators for manuscript development, including conducting advanced statistical analyses and writing statistical methods and results sections. • Supporting (New Product Development) NPD team members in conducting statistical analyses for scientific evidence publications and presentations for Exactech products. • Consulting with test design engineers regarding statistical analyses and appropriate statistical methods to use in product Verification and Validation (V&V) testing. • Collaborate with the IT staff and 3rd party technology providers to resolve issues. • Recommend strategies to optimize/standardize/automate business processes to enable improved clinical data management. • Participate in new technology training and adoption of analytics software. • Conducting research in compliance with applicable Exactech policies/procedures and FDA, ISO, ICH/GCP and HIPAA requirements. • Participating on project teams to provide statistical strategy and planning support as required over the duration of the project. • May provide statistical input and support for other Exactech functional areas as required (e.g., Quality, Marketing, and Marketing Communications). • Participating in continuing biostatistics education and maintaining professional memberships/activities. • Knowing and applying Exactech’s Quality Management System and any appropriate federal and international standards. • Assisting and supporting other employees, teams, and sales personnel as necessary. • Practicing Exactech’s Values.

Requirements

• Bachelor’s Degree in Biostatistics; Master’s Degree preferred • Minimum 3 years’ experience in biostatistical research (epidemiology / clinical) projects required • Biostatistics experience in medical device / orthopedics research preferred • Experience with predictive analytics/machine learning models preferred • Strong proficiency in statistical analysis software programs • Hands-on expertise with database tools (SQL) • Hands-on coding experience with data tools (R, MATLAB, Python) • Demonstrated statistical skills as evidenced by participation in publications or presentations in areas relevant to pre-clinical and clinical research and biostatistical methods • Excellent verbal and written communication skills • Detail-oriented with strong organizational skills • Creative problem-solving and critical thinking skills • Flexibility and willingness to work with a variety of team members • Strong technical writing skills • Familiarity with EDC/CTMS/CDMS systems (IBM CD) • Working knowledge of MS Office database platforms, spreadsheets and graphical presentation programs

Benefits

• None