Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSBST2

Position Description

This position is full-time. (Part-time, contract, and contract-to-permanent candidates will be considered, depending upon experience.)

• Successfully support the Clinical Solutions Practice Leader in the execution of clinical development programs in accordance with operating timelines, GCP-compliant Standard Operating Procedures, and other applicable SOPs and regulations
• Uphold processes that ensure the absolute integrity of clinical study data sets, analysis, and Clinical Study Reports
• Interface with database development and clinical development program management staff to provide guidance in statistical analyses methodology
• Support the performance of statistical programming, design, and analysis for all clinical trial projects
• Supervise project team members in all aspects of design and statistical analyses, and reporting on clinical research
• Support the development of sample size calculations, interim looks, Statistical Consideration sections, randomizations, and study design recommendations for all clinical protocols and case report forms
• Support the development and implementation of statistical plans and specification documents
• Project a mature, professional image and provide responsive, meaningful, high-quality follow-up to client and internal inquiries
• Develop and maintain a daily workplan and calendar that tracks activities, milestones, and deadlines
• Support the maintenance of documentation, filing, tracking, and information retrieval systems
• Develop and maintain the requisite computer skills to effectively utilize state-of-the-art office equipment and systems (Ongoing testing and certifications may be expected.)
• Understand and comply with Standard Operating Procedures and work instructions
• Perform other duties as may be assigned by the Director of Biostatistics or senior management
• Report to the Director of Biostatistics

• Minimum 3-5 years successful clinical operations and regulatory experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research industries. Prior experience with SAS programming required
• Fluency in harmonized GCP standards, the medical device product development and approval process, and 21CFR Part 11
• Working knowledge of non-sequential and sequential clinical trial methodologies, advanced statistical theory and methods including specific knowledge of experimental design, analysis of variance and linear models, survival analysis, categorical analysis, multivariate analysis, robust estimation, and nonparametric techniques is preferred
• Comprehensive understanding of the medical product development process
• Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
• Successful, significant contributions to Class II and III medical device regulatory submissions and approvals
• Undergraduate degree in biostatistics or another relevant discipline from a leading university
• Certifications in Microsoft Windows and Office applications required
• Must be willing to relocate to the Boston area permanently, for up to 2 years
• Excellent presentation and communication (both oral and written) skills
• Excellent time management, planning, and teamwork skills
• Must be willing to work hours as needed to meet deadlines and needs

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