Associate Director, Statistical Programming
InvivydConnecticut, United States
Posted October 3, 2025
Full Time
About the Company
Invivyd, Inc. (Nasdaq: IVVD) specializes in developing potent, virus-resistant medicines using a proprietary integrated technology platform. The company focuses on creating best-in-class antibodies through advanced assessment and adaptation techniques. In March 2024, Invivyd received emergency use authorization for a monoclonal antibody, highlighting its innovation in treating immune-compromised patients.
Job Description
Invivyd is seeking an Associate Director of Statistical Programming to lead statistical programming efforts for a variety of compounds and BLA/MAA-related activities. The role involves managing CROs, ensuring quality and regulatory compliance, and contributing to the development of statistical programming strategies. The company is focused on developing novel antibody candidates and making a difference in the fight against viral infectious diseases.
Requirements
- BS in statistics, biostatistics, engineering, computer science or equivalent area
- 8+ years of experience in statistical programming within the pharmaceutical industry
- Excellent SAS software programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development (SAS certification is required)
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)
- Extensive experience in defining and implementing CDISC compliant SDTM and ADaM data and specifications
- Must be able to travel to New Haven, CT office at least 1x a month
