Biostatistician

Description The biostatistician role provides biostatistics planning and support to Exactech research initiatives. Key Responsibilities The duties of the biostatistician will support the following areas: Clinical Research and Regulatory Affairs 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. Engineering and Development 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 with the clinical data management systems and tools. Recommend strategies to optimize/standardize/automate business processes to enable improved clinical data management, an improved external customer experience, and increased end user productivity. Collaborate with the IT staff and 3rd party technology providers to resolve issues with the clinical data management systems and tools. 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.q., 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. Skills Knowledge and Expertise Education: Bachelor’s Degree in Biostatistics; Master’s Degree preferred Experience: 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 Functional/Technical Knowledge, Skills and Abilities Required: 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 About Exactech About Exactech Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.