Senior Manager, Statistical Programming

<div class="content-intro"><p>Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. </p></div><p><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">We are seeking an experienced </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Senior Manager, Statistical </span><span data-ccp-charstyle="normaltextrun">Programming</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun"> to drive the development and validation of statistical programs for late-stage clinical studies. In this role, you will ensure programming activities align with SOPs and regulatory requirements, delivering high-quality and </span><span data-ccp-charstyle="normaltextrun">timely</span><span data-ccp-charstyle="normaltextrun"> results. This is an exciting opportunity to contribute to critical drug development efforts while driving efficiency and compliance in statistical programming.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{"ObjectId":"920dbcde-2834-5e15-a5fa-062170b236ba|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri",268442635,"22",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"Default Paragraph Font"]}"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">RESPONSIBILITIES</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Lead the development and validation of statistical programs to ensure high-quality deliverables for both in-house and outsourced projects, adhering to company and regulatory requirements.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Drive ISS/ISE analysis tasks in support of NDA submissions.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Assist</span><span data-ccp-charstyle="eop"> in planning and coordinating </span><span data-ccp-charstyle="eop">project work to ensure </span><span data-ccp-charstyle="eop">timely</span><span data-ccp-charstyle="eop"> and high-quality delivery across multiple studies.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Develop and r</span><span data-ccp-charstyle="eop">eview programming plan</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">,</span><span data-ccp-charstyle="eop"> dataset</span><span data-ccp-charstyle="eop"> specifications</span><span data-ccp-charstyle="eop">, </span><span data-ccp-charstyle="eop">and TLFs</span><span data-ccp-charstyle="eop">;</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">a</span><span data-ccp-charstyle="eop">pply</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">expertise</span><span data-ccp-charstyle="eop"> in </span><span data-ccp-charstyle="eop">CDISC standards, including SDTM and </span><span data-ccp-charstyle="eop">ADaM</span><span data-ccp-charstyle="eop"> models</span><span data-ccp-charstyle="eop">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Review documents produced by biometric functions such as SAP</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, CRF</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, data review plan</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, </span><span data-ccp-charstyle="eop">and </span><span data-ccp-charstyle="eop">data transfer </span><span data-ccp-charstyle="eop">agreement</span><span data-ccp-charstyle="eop">s.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Oversee </span><span data-ccp-charstyle="eop">CRO programming activitie</span><span data-ccp-charstyle="eop">s,</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">review</span><span data-ccp-charstyle="eop">ing</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">an</span><span data-ccp-charstyle="eop">d validat</span><span data-ccp-charstyle="eop">ing CRO </span><span data-ccp-charstyle="eop">deliverables including</span><span data-ccp-charstyle="eop"> SDTM, </span><span data-ccp-charstyle="eop">ADaM</span><span data-ccp-charstyle="eop"> and TLFs, </span><span data-ccp-charstyle="eop">while </span><span data-ccp-charstyle="eop">provid</span><span data-ccp-charstyle="eop">ing</span><span data-ccp-charstyle="eop"> solutions to </span><span data-ccp-charstyle="eop">any </span><span data-ccp-charstyle="eop">issues raised by CROs</span><span data-ccp-charstyle="eop">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Review </span><span data-ccp-charstyle="eop">e</span><span data-ccp-charstyle="eop">S</span><span data-ccp-charstyle="eop">ub</span><span data-ccp-charstyle="eop">mission</span><span data-ccp-charstyle="eop"> datasets and data documentation</span><span data-ccp-charstyle="eop"> such as</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">aCRF</span><span data-ccp-charstyle="eop">, reviewer guide</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, define document</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop"> and programs to ensure all files meet submission requirements. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Develop macros to support study and project activities</span><span data-ccp-charstyle="eop">,</span><span data-ccp-charstyle="eop"> contribut</span><span data-ccp-charstyle="eop">ing </span><span data-ccp-charstyle="eop">to </span><span data-ccp-charstyle="eop">global macro tools that </span><span data-ccp-charstyle="eop">enhance the </span><span data-ccp-charstyle="eop">overall efficiency and </span><span data-ccp-charstyle="eop">capacity</span><span data-ccp-charstyle="eop"> of </span><span data-ccp-charstyle="eop">the </span><span data-ccp-charstyle="eop">programming function</span><span data-ccp-charstyle="eop">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Maintain deep f</span><span data-ccp-charstyle="eop">amiliar</span><span data-ccp-charstyle="eop">ity</span><span data-ccp-charstyle="eop"> with ICH guidelines</span><span data-ccp-charstyle="eop"> and </span><span data-ccp-charstyle="eop">advanced knowledge of </span><span data-ccp-charstyle="eop">regulatory </span><span data-ccp-charstyle="eop">submission requirements</span><span data-ccp-charstyle="eop">, </span><span data-ccp-charstyle="eop">ensur</span><span data-ccp-charstyle="eop">ing</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">all </span><span data-ccp-charstyle="eop">statistical programming deliverables</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">meet </span><span data-ccp-charstyle="eop">industry and company standards.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Support the preparation of clinical study reports, regulatory submissions, DSUR</span><span data-ccp-charstyle="eop">s,</span><span data-ccp-charstyle="eop"> and safety reports</span><span data-ccp-charstyle="eop"> across</span><span data-ccp-charstyle="eop"> multiple studies</span><span data-ccp-charstyle="eop">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">Contribute to the development, </span><span data-ccp-charstyle="eop">implementation</span><span data-ccp-charstyle="eop"> and continuous improvement of programming process</span><span data-ccp-charstyle="eop">es</span><span data-ccp-charstyle="eop"> and standard</span><span data-ccp-charstyle="eop">s.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto"><span data-ccp-charstyle="eop">C</span><span data-ccp-charstyle="eop">ommunicate</span><span data-ccp-charstyle="eop"> effectively</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">within </span><span data-ccp-charstyle="eop">project team</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, </span><span data-ccp-charstyle="eop">across </span><span data-ccp-charstyle="eop">department</span><span data-ccp-charstyle="eop">s</span><span data-ccp-charstyle="eop">, </span><span data-ccp-charstyle="eop">and with external collaborators. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559685":720,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">THE IDEAL CANDIDATE</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Expert-level SAS programmer with a proven track-record of delivering complex programming assignments and analyses.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Skilled in writing original cold, developing macros and modifying existing code.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Experience in developing and implementing statistical programming standards and procedures.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Expert level knowledge and extensive hands-on experience with CDISC standards including CDASH, SDTM, and ADaM.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Experience leading teams supporting FDA, EMEA, and CDE regulatory filings.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Strong interpersonal skills with excellent written and verbal communication.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Meticulous attention to detail and consistency.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559685":1080,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">EDUCATION</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Bachelor’s degree (or equivalent), preferably in a computational or biological science, with a minimum of 8 years of direct experience in drug development. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Master’s degree with minimum of 6 years of related experience. </span><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">This position </span><span data-ccp-charstyle="normaltextrun">is located in</span><span data-ccp-charstyle="normaltextrun"> South San Francisco, CA. At this </span><span data-ccp-charstyle="normaltextrun">time</span><span data-ccp-charstyle="normaltextrun"> we are not considering remote applicants.</span></span></strong><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="eop">The salary range for this position is $180,000 - $210,00 </span></span><span data-contrast="auto"><span data-ccp-charstyle="eop">USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p><em><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Alumis</span><span data-ccp-charstyle="normaltextrun"> Inc. is an equal opportunity employer. </span></span></em><span data-contrast="auto"><span data-ccp-charstyle="eop"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p>