Director, Biostatistics, Pulmovant at Pulmovant

Remote, USFull-timeRemoteBiometricsPosted 20 days ago

About the Role

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.   Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release <a href="https://investor.roivant.com/news-releases/news-release-details/roivant-announces-positive-results-phocus-study-mosliciguat">here</a>.  As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.  For more information, please visit <a href="https://www.pulmovant.com/">https://www.pulmovant.com</a>.  About Roivant:  Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit <a href="http://www.roivant.com/">www.roivant.com</a>.   Position: Director, Biostatistics  Summary:    Pulmovant is seeking a Director of Biostatistics to serve as lead biostatistician for its Phase 3 PHrontier program evaluating mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD). This role will drive statistical strategy for the pivotal trial, partnering closely with Clinical Development, Regulatory, and Data Management to ensure rigorous, submission-ready trial design and analysis. The ideal candidate brings direct experience taking a program through Phase 3 and toward regulatory filing.  Key Duties and Responsibilities   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Serve as lead biostatistician for Pulmovant's Phase 3 PHrontier program, including protocol development, statistical analysis plans (SAPs), and sample size/power calculations </li> <li>Partner with Clinical Development and Regulatory on trial design decisions, including endpoint selection and interim analysis strategy </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Oversee CRO/vendor biostatistics deliverables, ensuring quality and timeline adherence </li> <li>Lead statistical input for regulatory submissions (e.g., NDA/BLA), including responses to health authority queries </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Collaborate with Data Management on CRF design, database structure, and data quality standards </li> <li>Present statistical results and methodology to internal leadership and external stakeholders (e.g., DSMBs, advisory boards) </li> <li>Mentor junior biostatistics staff or contractors as the function scales </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Contribute to departmental initiatives, standards, process improvements, talent development, resource planning, and inspection readiness. </li> </ul> Education and Experience   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="47" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">PhD or MS in Biostatistics, Statistics, or related field </li> <li>8+ years of biostatistics experience in clinical drug development, including direct Phase 3 experience </li> <li data-leveltext="·" data-font="Symbol" data-listid="47" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Prior experience contributing to a regulatory submission (NDA/BLA) strongly preferred </li> <li>Pulmonary/respiratory therapeutic area experience a plus </li> </ul> Essential Skills and Abilities   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Deep expertise in SAS and/or R for clinical trial analysis </li> <li>Strong understanding of ICH/FDA statistical guidance and GCP, ICH standards, and CDISC principles </li> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Experience managing CRO biostatistics relationships </li> <li>Excellent cross-functional communication skills, able to translate statistical findings for non-statistician stakeholders </li> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Comfortable operating in a lean, scaling clinical-stage environment </li> </ul>   Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.   We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

About the Role

Related Roles