Manager/Senior Manager, Statistical Programming, Pulmovant

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 here.
As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.
For more information, please visit https://www.pulmovant.com.
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 www.roivant.com.
Position: Manager / Senior Manager, Statistical Programming
Summary:
Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support the development and delivery of high-quality, submission-ready programming deliverables across our pulmonary/respiratory clinical portfolio. This individual will serve as a lead programmer on clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure that all CDISC-compliant datasets, TLFs, and electronic submission packages meet the highest standards of quality and regulatory compliance.
Key Duties and Responsibilities
Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions
Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files
Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines
Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards to improve efficiency and consistency across programs
Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests
Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml
Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans from a programming perspective
Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs to align on timelines and deliverables