Director, Biostatistics , Biometric Sciences

Viridian Therapeutics, Inc.; United States; Hybrid; USD 170,000 - 250,000; Full time

Benefits offered by this job

Competitive pay

Stock options

Medical, dental, vision insurance

Disability and life insurance

401(k) company match

Employee stock purchase plan

Generous vacation and holidays

Job summary

Viridian Therapeutics, Inc. is seeking a Director of Biostatistics to lead statistical strategy across development programs. Hybrid role based in Waltham, MA or remote with occasional meetings at HQ.

You will guide study design, analysis plans, and regulatory interactions, mentoring staff and collaborating with CROs and internal teams. The role requires a PhD with 8+ years (or MS with 12+ years) in biostatistics, strong SAS/R/Python skills, and deep regulatory knowledge.

Qualifications

• PhD (or equivalent) with 8+ years in biotech/pharma/CROs; MS with 12+ years.
• Excellent statistical knowledge and application to clinical problems; rare diseases preferred.
• Proficiency in SAS, R or Python and advanced statistical methods.
• Working knowledge of FDA/ICH guidelines and regulations.
• Experience managing CROs, vendors and stakeholder relationships.
• Leadership in cross-functional teams and statistical programming oversight.
• Experience with CDISC submission packages and regulatory interactions.

Responsibilities

• Lead biostatistics strategy for clinical development programs and teams.
• Champion innovative statistical thinking to support development success.
• Collaborate with Data Management and internal/external stakeholders.
• Apply quantitative approaches to diverse data types and analyses.
• Manage contractors/consultants and mentor team members.
• Oversee statistical sections of plans, protocols and SAPs.
• Plan and track biostatistics activities, timelines and resources.
• Interact with regulatory agencies and respond to statistical questions.
• Review SOPs and work instructions related to biostatistics.
• Collaborate with CROs, vendors and partners to meet milestones.
• Represent Viridian at professional societies and industry discussions.
• Budget authority and resource allocation aligned with project needs.

Skills

Biostatistics leadership

Statistical analysis

SAS

R

Python

Regulatory knowledge

Team management

CRO/vendor management

Education

PhD in Biostatistics

MS in Biostatistics

Tools

CDISC SDTM

ADaM

SAS/STAT

Define.xml

GxP/SOPs

Job 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

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
• 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 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.