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Senior Director, Biostatistics

generatebiomedicines · Somerville, MA · Somerville, Massachusetts, United States
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<p><strong>The Role: </strong></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">The Senior Director, Biostatistics is </span><span data-ccp-parastyle="Normal (Web)">a statistical </span><span data-ccp-parastyle="Normal (Web)">leader responsible for defining and executing statistical strategy </span><span data-ccp-parastyle="Normal (Web)">for</span><span data-ccp-parastyle="Normal (Web)"> late-stage</span> <span data-ccp-parastyle="Normal (Web)">development</span><span data-ccp-parastyle="Normal (Web)"> program</span><span data-ccp-parastyle="Normal (Web)">, and regulatory readiness</span><span data-ccp-parastyle="Normal (Web)">. </span><span data-ccp-parastyle="Normal (Web)">This</span><span data-ccp-parastyle="Normal (Web)"> Senior Director, Biostatistics will report to Head of Biometrics and</span> <span data-ccp-parastyle="Normal (Web)">expected to </span><span data-ccp-parastyle="Normal (Web)">partner closely with Clinical Development, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology to ensure scientific </span><span data-ccp-parastyle="Normal (Web)">rigorous </span><span data-ccp-parastyle="Normal (Web)">trial execution</span><span data-ccp-parastyle="Normal (Web)">, </span><span data-ccp-parastyle="Normal (Web)">and informed decision-making from early development through registration. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559740":240}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">The Senior Director will </span><span data-ccp-parastyle="Normal (Web)">be </span><span data-ccp-parastyle="Normal (Web)">directly responsible</span><span data-ccp-parastyle="Normal (Web)"> for critical </span><span data-ccp-parastyle="Normal (Web)">statistical </span><span data-ccp-parastyle="Normal (Web)">deliverables, </span><span data-ccp-parastyle="Normal (Web)">demonstrat</span><span data-ccp-parastyle="Normal (Web)">ing</span><span data-ccp-parastyle="Normal (Web)"> both</span><span data-ccp-parastyle="Normal (Web)"> strategic leade</span><span data-ccp-parastyle="Normal (Web)">rship </span><span data-ccp-parastyle="Normal (Web)">and </span><span data-ccp-parastyle="Normal (Web)">hands-on</span> <span data-ccp-parastyle="Normal (Web)">ownership and ensur</span><span data-ccp-parastyle="Normal (Web)">ing</span><span data-ccp-parastyle="Normal (Web)"> alignment across internal teams and external partners. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559740":240}"> </span></p> <p><strong>Here's how you'll contribute: </strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" 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-parastyle="Normal (Web)">Lead statistical strategy across clinical programs to align with development </span><span data-ccp-parastyle="Normal (Web)">objectives</span><span data-ccp-parastyle="Normal (Web)"> and regulatory expectations.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="15" 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-parastyle="Normal (Web)">Provide </span><span data-ccp-parastyle="Normal (Web)">statistical </span><span data-ccp-parastyle="Normal (Web)">leadership for late-stage development, including </span><span data-ccp-parastyle="Normal (Web)">pragmatic application of </span><span data-ccp-parastyle="Normal (Web)">adaptive, Bayesian, </span><span data-ccp-parastyle="Normal (Web)">or innovative designs </span><span data-ccp-parastyle="Normal (Web)">where </span><span data-ccp-parastyle="Normal (Web)">appropriate</span><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" 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-parastyle="Normal (Web)">Draft and review</span> <span data-ccp-parastyle="Normal (Web)">SAP</span><span data-ccp-parastyle="Normal (Web)">s</span><span data-ccp-parastyle="Normal (Web)">, </span><span data-ccp-parastyle="Normal (Web)">statistical components of </span><span data-ccp-parastyle="Normal (Web)">protocols, </span><span data-ccp-parastyle="Normal (Web

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