Description:
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.
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 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 there Represent Viridian at professional societies, and in industry-wide technical discussions
Requirements
Qualifications:- 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, vendors, and relationship management preferred
Demonstrated proficiency in statistical processes including but not limited to CRF review, development of randomization lists, development of statistical analysis plan, development of CDISC submission package (SDTM, ADaM, define xml, reviewer guides), development of analysis output and review of clinical study report
Experience in managing external vendors
Prior experience supporting one or more successful BLA, NDA or MAA submissions and participating in regulatory agency meetings is strongly preferred
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment
Ability to effectively collaborate in a dynamic, cross-functional matrix environment
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 10%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 insurance 100% Paid Parental Leave Short- and long-term disability coverage
Life, Travel and AD&D401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
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.
Employee Type: FT Exempt
