Full-Time
Associate Director
Statistical Programming
Posted on 10/4/2025
Invivyd
51-200 employees
Develops monoclonal antibodies for viral protection
No salary listed
New Haven, CT, USA
Hybrid
Must be able to travel to New Haven, CT office at least 1x per month.
 Biology & Biotech (2) |
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- BS in statistics, biostatistics, engineering, computer science or equivalent area with 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
- Lead statistical programming and regulatory submission activities
- Manage CROs to meet timelines and expectation of quality
- Collaborate with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines
- Create and validate SDTM, ADaM, and TLFs
- Create, validate, and document complex and reusable macros for data cleaning, validation, analysis, customized report and graph generation, and integration of data
- Write and review the data specification of SDTM and ADaM data sets
- Track clinical trial milestones and work with vendors for statistical reporting deliverables
- Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation
- Understands and performs in accordance with regulatory standards and drug development principles
- Responsible for the creation and accuracy of regulatory submission data and clinical summary report package
Invivyd develops antibody-based therapies to protect immunocompromised people from viral threats. It discovers and optimizes monoclonal antibodies using viral surveillance, predictive modeling, and antibody engineering, aiming to prevent infections such as COVID-19 in high-risk groups. Its lead candidate VYD222 targets prevention of symptomatic COVID-19 in transplant recipients and people with blood cancers. The company plans to commercialize these antibodies through development, approvals, and partnerships, while pursuing government funding to support research for vulnerable populations.
Company Size
51-200
Company Stage
IPO
Headquarters
Waltham, Massachusetts
Founded
2020
Simplify's Take
What believers are saying
- DECLARATION Phase 3 trial fully enrolled with mid-2026 data readout for VYD2311 launch.
- PEMGARDA revenue grew 31% sequentially in Q4 2025, validating antibody prophylaxis market demand.
- Pipeline expansion into measles, RSV, and long COVID addresses multiple high-need viral indications.
What critics are saying
- Low COVID community attack rates force 30% trial expansion, risking 6-9 month data delay.
- Stock price below $1 triggers Nasdaq delisting risk, halting institutional investment and capital access.
- Competing extended half-life COVID antibodies from AstraZeneca and Regeneron capture immunocompromised market share.
What makes Invivyd unique
- Proprietary platform combines viral surveillance, predictive modeling, and antibody engineering for evolved immunity.
- Targets immunocompromised populations underserved by traditional vaccines with monoclonal antibody prophylaxis.
- FDA Fast Track designation for VYD2311 accelerates COVID-19 prevention development versus competitors.
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Benefits
Remote Work Options
Professional Development Budget
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↓ -5%2 year growth
↓ -1%Invivyd reported Q4 2025 earnings, highlighting strategic progress in monoclonal antibody prophylaxis as an alternative to COVID-19 vaccine boosting. The company's Declaration study for VYD2311 reached target enrolment of approximately 1,770 subjects, with mid-year 2026 remaining the target for pivotal data. PEMGARDA revenue grew 31% sequentially, supporting infrastructure development ahead of a potential VYD2311 launch. Management expects to decide on expanding the trial by roughly 30% in April to ensure statistical power if community attack rates fluctuate. The company reported cash of $226.7 million, providing runway through the mid-2026 data readout. Invivyd is expanding into long COVID and post-vaccine syndrome, whilst developing RSV and measles programmes with a paediatric-first approach. Management cited COVID-19 community attack rates as the primary external risk factor.
Invivyd has appointed Michael Mina, M.D., Ph.D., as Chief Medical Officer. Dr Mina is a former assistant professor of epidemiology, immunology and infectious disease at Harvard T.H. Chan School of Public Health and pathology at Harvard Medical School and Brigham and Women's Hospital. Dr Mina gained prominence during the COVID pandemic, advising governments on testing policies and leading the US government's Home Test-to-Treat Programme. His research includes discovering measles-induced "immune amnesia" and investigating antibody responses to vaccines and pathogens. He has published over 100 scientific papers with more than 10,000 citations. The appointment comes as Invivyd works to expand its pipeline of monoclonal antibodies for infectious disease prevention, including COVID, RSV and measles.
Invivyd reported fourth quarter 2025 net product revenue of $17.2 million for PEMGARDA (pemivibart), representing 25% year-over-year growth and 31% quarter-over-quarter growth. Full-year revenue more than doubled whilst operating expenses were reduced by nearly half. The company ended 2025 with $226.7 million in cash after raising over $200 million in financing transactions during the second half of the year. Invivyd has initiated the DECLARATION Phase 3 pivotal trial of VYD2311, a vaccine-alternative antibody to prevent COVID, with top-line data expected mid-2026. The FDA granted Fast Track designation for VYD2311 in December 2025. The trial has achieved full enrolment and an independent data monitoring committee has recommended allowing pregnant and breastfeeding women to participate. A potential trial re-sizing decision could occur in April.
Invivyd announced an underwritten public offering of its common stock, with all shares offered by the company. The proceeds will be used for commercial preparedness for VYD2311, R&D for pipeline programs like respiratory syncytial virus and measles, advancement of the SPEAR Study Group on monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and general corporate purposes. Cantor is the sole book-running manager for the offering.
Invivyd has announced the successful closing of a public offering, raising $57.5 million. The underwriter also fully exercised their option to purchase additional shares.