Remote Director, Biostatistics & Clinical Development

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

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.