Associate Director, CMC Statistician

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3> <div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. </div> <div> </div> <div><strong>WHAT</strong> we do is every bit as important as <strong>HOW</strong> we do it! Our work together is guided by four enduring core values:</div> <div> </div> <div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div> <div> </div> <div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div> <div> </div> <div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div> <div> </div> <div>*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><p><strong>Summary:</strong></p> <p>Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an integral part of the Vaccine Specification Working Group (VSWG), providing statistical leadership for specification setting and Justification of Specifications (JOS) across late-stage development, PPQ, BLA readiness, and commercial lifecycle management. This individual will collaborate with Process Development, MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external partners to develop statistically sound, patient-centric, and regulatory-ready approaches. The ideal candidate will bring deep CMC statistics experience in biotech/pharma, excellent technical writing and communication skills, and a practical, data-driven approach to cross-functional decision making.</p> <p><strong>Essential Functions:</strong></p> <ul> <li>Serve as the CMC statistical lead for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stabil