pstrongRole:: Director of Data and Biostatistics/strong/ppstrongLocation :: Acton MA 01720 - 3 Days/Week /strong/ppstrongDuration :: 12+ Months - Extension Possible/strong/pp/ppstrongJob Description: /strong/ppThe Director of Data and Biostatistics will lead data operations for our Clinical Affairs team focused on medical devices. This role will be responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. In addition, this role will be responsible for overseeing the statistical analysis of clinical study data ensuring appropriate statistical methods and accurate analyses to evaluate efficacy and safety and answer research related questions./pp/ppstrongResponsibilities:/strong/pulliLead the development and execution of data management strategies for clinical trials involving medical devices./liliSupport the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met./liliLead the development and execution of statistical analysis plans for clinical studies./liliOversee the design and validation of clinical databases (e.g., EDC systems) and ensure alignment with study protocols and regulatory requirements./liliCollaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance./liliEnsure high-quality data collection, cleaning, and reporting processes./liliManage data management and biostatistics vendors and CROs, ensuring deliverables are met on time and within budget./liliDevelop and maintain SOPs and best practices for biostatistics and data management activities./liliProvide leadership and mentorship to data management and biostatistics staff. This role will have direct reports./liliPerforms other duties as required./li/ulpbr / strongEducation and Experience:/strong/pulliMaster#39;s degree in Life Sciences, Health Informatics, Biostatistics, or related field./liliMinimum of 8-10 years of data management and/or biostatistics experience in clinical research, with at least 3 years in a leadership role./liliStrong background in medical device clinical trials and understanding of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155)./liliKnowledgeable in statistical methods./liliProficiency with clinical data systems (e.g., Medidata Rave, Oracle InForm, REDCap)./liliExperience with device data integration and analysis./liliSolid understanding of database design, data standards (e.g., CDISC), and data quality assurance./liliExcellent communication, leadership, and project management skills./li/ulpbr / strongSkills/Competencies:/strong/pulliExcellent written and effective verbal communication skills./liliAbility to communicate cross-functionally across the organization./liliPC skills; word processing, spreadsheet, database, Internet search, and utilization./liliFlexible and able to work in a fast-paced environment./liliTeam player./liliAbility to organize and judge priorities./liliExcellent ability to generate and maintain accurate records./li/ulpDexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support. br / br /Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.br / br /Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status./p