Associate Director, Statistical Programming

About this role

<p><strong><span data-contrast="none">Company:</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none">At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together. </span><span data-contrast="auto"> </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none">For more information on Annexon and our pipeline, check out our site </span><a href="https://annexonbio.com/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Annexon Biosciences</span></span></a> <span data-contrast="none">& </span><a href="https://annexonbio.com/pipeline/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Annexon Pipeline</span></span></a><span data-contrast="none">. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335557856":16777215,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p>We're seeking <strong>exceptional talent</strong> from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company <a href="https://annexonbio.com/our-culture/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">culture</span></span></a><span data-contrast="auto">!</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="none">Position:</span></strong><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></p> <p>Reporting to the Head of Statistical Programming, this individual independently operates and oversees the development and delivery of statistical programming solutions for all Annexon clinical trials and regulatory submissions. A highly visible and collaborative role, the Associate Director of Statistical Programming partners cross-functionally to advance medicines to our patients. </p> <p><strong><span data-contrast="none">Responsibilities include:</span></strong><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></p> <ul> <li>Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full E2E traceability.</li> <li>Serve as lead statistical programmer on one or more clinical studies.</li> <li>Conducts gap analysis and risk assessments for global submissions such as BLA/MAA etc.</li> <li>Reviews SAP, TFL shells, eCRFs etc.</li> <li>Maintain complete and auditable documentation for all statistical programming activities.</li> <li>Develop and/or verify CDISC SDTM/ADaM specifications, datasets and eCRT submission packages such as define.xml, reviewer’s guide’s etc. </li> <li>Support supplemental/ad hoc/post hoc requests for submissions, publications and manuscripts.</li> <li>Provide guidance to project/study teams.</li> <li>Participate cross-functionally with key partners to advance Annexon products.</li> <li>Contribute to and participate in the development and maintenance of a positive team-focused company culture.</li> </ul> <p><strong><span data-contrast="none">Education, Experience, and Skills:</span></strong><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></p> <p><strong><span data-contrast="none">Required:</span></strong><span…