Overview As Director, Biostatistics you will lead the biostatistics strategy and execution across Viridian's monoclonal antibody programs, ensuring rigorous analyses and timely, high-quality outputs. You will partner with clinical development to shape study design, analysis plans, and regulatory interactions, contributing to transformative medicines for patients. This leadership role spans cross-functional collaboration, vendor management, and regulatory engagement, with a hybrid/fully remote setup and travel as needed. You will drive innovative statistical methods and data-driven decision making within a fast-paced, mission-driven organization.
Compensation / Benefits- Competitive pay and stock options
- Comprehensive medical, dental, and vision insurance
- 100% paid parental leave
- Short- and long-term disability coverage
- Life, Travel and AD&D
- 401(k) company match and employee stock purchase plan
Responsibilities- Lead biostatistics strategy for clinical development programs and manage teams to deliver timely, high-quality results
- Introduce innovative, fit-for-purpose statistical methods to improve program success probability
- Collaborate with Data Management and other stakeholders to apply quantitative approaches across diverse data types
- Provide guidance and mentorship to contractors, consultants, and internal staff
- Oversee statistical sections of CDPs, SAPs, and specifications for statistical programming
- Plan and track biostatistics activities, timelines, and budgets to ensure operational excellence
- Engage with regulatory agencies to address statistical questions and requests
- Draft or review SOPs and work instructions for biostatistics practices
- Coordinate with CROs, software vendors, and clinical development partners to meet timelines
- Represent Viridian in professional societies and industry discussions
Key requirements- PhD with 8+ years of relevant experience in Biotech, Pharma, regulatory agencies, or CROs
- Proficiency in SAS, R, or Python; experience with advanced statistical analyses
- Strong knowledge of FDA/EU/ICH guidelines and regulatory expectations
- Experience managing CROs, vendors, and cross-functional teams; budget management
- Experience supporting one or more BLA/NDA/MAA submissions and regulatory meetings preferred
- Excellent communication skills and ability to work in a fast-paced, cross-functional environment
- Willingness to travel up to 10%
- Experience with CDISC SDTM/ADaM and define.xml, reviewer guides
- Proven track record in statistical programming and clinical study reporting
- Knowledge of randomization, CRF review, and statistical analysis plan development
- excellent communication (verbal and written)
- team leadership and mentorship
- cross-functional collaboration
- SAS
- R
- Python
