Director, Biostatistics , Biometric Sciences

• Location Remote - Waltham, MA, United States
• Base Pay $ - $ / Year
• Employee Type FT Exempt
• Required Degree Masters
• Travel 10%
• Manage Others No

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Executive Director, Biometric Sciences, the Director, Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Viridian’s development programs that are leveraging our cutting-edge Monoclonal antibody science to create transformative medicines for patients. This role is an exciting opportunity to lead and collaborate as a critical part of the clinical development group of a high performing organization.

This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

• Serve as the biostatistics leader & partner to our clinical development team responsible for determining clinical study strategies and manage teams to deliver results with high quality and on time
• Champion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs
• Collaborate with internal and external Data Management stakeholders
• Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
• Provide guidance and management to contractors / consultants and manage / mentor supporting members to ensure high quality and timely deliverables.
• Oversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses
• Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
• Frequently interact with regulatory agencies and effectively address the statistical questions and requests
• Review and/or author SOPs and/or Work Instructions related to biostatistics practices
• Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Manage a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therei Represent Viridian at professional societies, and in industry-wide technical discussions

• PhD (or equivalent degree) with 8+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experience
• Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. Experience in Rare Diseases therapeutics clinical development is preferred
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Extensive experience and excellent skillsets in managing teams and engagement of CROs,…