Senior Director, Biostatistics, Biometric Sciences

At Viridian Therapeutics, 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. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

Reporting to the Executive Director, Biostatistics, Biometric Sciences, the Senior Director of Biostatistics, Biometric Sciences 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 (preferred) or remote. Employees local to our office are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Serve as the biostatistics leader & partner to our clinical development team responsible for determining clinical study strategies and manage junior staff to deliver results with high quality and on time
• Bring 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
• Collaboration 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 internal junior staff 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 best practices related to biometric science group
• Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Support functional or project budget for efficient allocation of company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein
• Represent Viridian at professional societies, and in industry-wide technical discussions

Qualifications:

• Requires a PhD (or equivalent degree) with 10+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 15+ 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 desired
• 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
• Experience in managing teams and engagement of CROs, vendors, and relationship management preferred
• Thorough knowledge in development of SDTM, ADaM packages and development of analysis output
• Experience in managing external vendors
• Experience with applicable regulatory rules and guidelines
• Excellent organizational skills and attention to detail
• Excellent written and verbal communication and interpersonal skills
• Able to set priorities and manage multiple projects and demands
• Able to think critically and independently and be a proactive problem-solver
• Able to work independently while exercising initiative, flexibility, and sound judgment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 20%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Competitive medical, dental, and vision coverage
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.